List of iSPE Classroom Training Courses | ISPE | International Society for Pharmaceutical Engineering

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</div> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Biotechnology</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="227835" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Biopharmaceuticals: C&GT and ATMP Training Course (T68)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell platforms are presented as the two most common and established therapeutic technologies for Gene Therapy and Cell Therapy, respectively. The purpose of this course it to provide a fundamental</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biopharmaceuticals-cgt-atmp" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="226806" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Biopharmaceuticals: CMC Aspects Training Course (T67)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biopharmaceuticals-cmc-aspects" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="226638" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Biopharmaceuticals: Introduction to Large Molecule Therapeutics Training Course (T66)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics. The need for Quality by Design in all aspects of biopharmaceutical development will be emphasized. Lastly, we’ll highlight the differences between small molecules and biomolecules (large molecules). The purpose of this course is to provide a fundamental understanding of the CMC aspects of biopharmaceuticals from development to market.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biopharmaceuticals-introduction-large-molecule-therapeutics" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133515" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Biotechnology Basics Training Course (T18)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biotechnology-basics" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144393" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Biotechnology Manufacturing Facility Design Training Course (T31)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biotechnology-manufacturing-facility-design-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133524" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Overview Biopharmaceutical Manufacturing Processes Training Course (T24) - Updated!</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/biopharmaceutical-manufacturing-processes" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133518" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Process Validation in Biotechnology Manufacturing (T32)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/process-validation-biotechnology-manufacturing" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Cleaning</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133583" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">CIP System Design, Integration and CIP Chemicals Training Course (T03)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/cip-system" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133584" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Cleaning Validation Principles Training Course (T17)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/cleaning-validation" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Commissioning and Qualification</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144660" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Commissioning and Qualification Training Course (T40)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/commissioning-qualification" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133612" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Facilities Management Training Course (T48)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/facilities-management-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="282906" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Good Engineering Practice in Support of Science and Risk-Based Commissioning and Qualification - Applying the ISPE Good Practice Guide, Second Edition: Good Engineering Practice (T75)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management (QRM)-based integrated Commissioning and Qualification (C&Q) as described in ISPE Baseline</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/good-engineering-practice-gep" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Facilities</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133583" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">CIP System Design, Integration and CIP Chemicals Training Course (T03)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/cip-system" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144660" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Commissioning and Qualification Training Course (T40)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/commissioning-qualification" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133612" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Facilities Management Training Course (T48)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/facilities-management-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133613" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GMP Sterile Pharmaceutical Manufacturing Facility Training Course (T12)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gmp-sterile-pharmaceutical-manufacturing" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144361" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">HVAC & Environmental Control for Life Science Facilities Training Course (T14)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/hvac-environmental-control-life-science-facilities-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133606" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharma Facilities Project Management Training Course (T26)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharmaceutical-facilities-management" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133611" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharmaceutical Water Systems (T35)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharma-water-systems" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133614" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Storage, Delivery, and Qualification Pharma Water Training Course (T23) </div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/storage-delivery-qualification-pharma-water" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>GAMP®</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133688" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21) </div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-5-gxp-compliance" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133690" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GAMP® Basic Principles Training Course (T07)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-basic-principles-2-day-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133689" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. Please click the "Locations and Registrations" table to select the two or three-day sessions.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-basic-principles-3-day-training" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="244708" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GAMP® Data Integrity 21 CFR Part 11 2-Day Training Course (T70)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-data-integrity-2-day-training" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133684" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course (T50)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-data-integrity-3-day-training" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>GMPs</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="175016" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Aseptic Processing and Annex 1 (T63)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/aseptic-processing-annex-1-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="134796" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GMP Auditing for Quality Assurance Training Course (G07)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gmp-auditing-quality-assurance" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="134798" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">GMP Fundamentals for the Pharmaceutical Industry (G01)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gmp-pharma-fundamentals" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144358" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/ich-q7a-gmps-active-pharmaceutical-ingredients" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="243527" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pre-Approval Inspection Readiness Training Course (T69)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pre-approval-inspection-readiness-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>HVAC</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144361" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">HVAC & Environmental Control for Life Science Facilities Training Course (T14)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/hvac-environmental-control-life-science-facilities-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Manufacturing</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="220803" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">ATMP Manufacturing Training Course T64</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/training/atmp-manufacturing" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144363" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Combination Products: Challenges and Expectations Training Course (T47)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Combination Products: Challenges and Expectations (T47) Overview With the increasing regulatory scrutiny on combination products, this new highly interactive course provides six (6) different aspects of a combination product which are: Combination Product GMPs Criticality of Design Input and how to define the requirements Design Verification and Validation approaches What to expect and considerations for Clinical Trial for Combination Products Human Factors for Combination Products Post Market Considerations An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/combination-products-challenges" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144358" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/ich-q7a-gmps-active-pharmaceutical-ingredients" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144365" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Implementing Process Analytical Technology Training Course (T29)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/implementing-process-analytical-technology" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144373" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Managing Cross Contamination with Risk-MaPP Training Course (T41)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will focus on using the logic diagram, how cross contamination control fits into the Quality System, how health-based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulation a Quality Risk Management Plan.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/cross-contamination-risk-mapp" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144399" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Operational Excellence in Pharma Operations Training Course (T56)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is designed to provide participants with a deep understanding of how to measure operational excellence including insights on relevant qualitative enablers as well as meaningful quantitative performance indicators.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/operational-excellence-pharma-operations" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144401" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Oral Solid Dosage Manufacturing Process Training Course (T10)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/oral-solid-dosage-manufacturing-process" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144402" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharmaceutical Technology Transfer Training Course (T19)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharmaceutical-technology-transfers" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144405" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Quality Risk Management Workshop (T42)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/quality-risk-management" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144412" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Turning QbD into a Practical Reality Training Course (T43)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/qbd" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Project Management</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133606" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharma Facilities Project Management Training Course (T26)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharmaceutical-facilities-management" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Quality by Design</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="174589" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Application of Engineering First Principles to Improve (Manufacturing) Operations in the Pharmaceutical (T60)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/first-principles-improve-pharma-manufacturing-operations-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144365" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Implementing Process Analytical Technology Training Course (T29)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/implementing-process-analytical-technology" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144414" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Process Validation Training Course (T46)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/process-validation" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144412" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Turning QbD into a Practical Reality Training Course (T43)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/qbd" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Quality Management Systems</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="263635" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Advancing Pharmaceutical Quality™ (APQ) Quality Management Maturity Training Course (T74)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">The ISPE Advancing Pharmaceutical Quality™ (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/apq-quality-management-maturity-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="251662" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">CAPA / RCA / Investigations Training Course (T73) </div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/capa-rca-investigations-training-course" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="155270" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Quality Management Systems Training Course (T57)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/quality-management-systems-agile-approach-product-realization-lifecycle" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Validation</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133584" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Cleaning Validation Principles Training Course (T17)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/cleaning-validation" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133688" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21) </div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/gamp-5-gxp-compliance" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133518" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Process Validation in Biotechnology Manufacturing (T32)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/process-validation-biotechnology-manufacturing" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="144414" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Process Validation Training Course (T46)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/process-validation" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> <ul class="accordion" data-accordion data-allow-all-closed="true" data-multi-expand="true"> <li class="accordion-item" data-accordion-item> <a href="#" class="accordion-title"> <h2>Water</h2> </a> <div class="accordion-content" data-tab-content id=""> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="220789" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Critical Utility GMP Compliance (T65)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/critical-utility-gmp-compliance" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133609" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharma Water Generation USP WFI & Purified Water Training Course (T04)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharma-water-generation" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133611" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Pharmaceutical Water Systems (T35)</div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/pharma-water-systems" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> <div> <div class="views-field views-field-rendered-entity"><span class="field-content"><div data-history-node-id="133614" class="node node--type-training-courses node--view-mode-product-accordion-description ds-1col clearfix"> <div class="field field--node-field-training-course-sht-title field--name-field-training-course-sht-title field--type-string field--label-hidden field__item">Storage, Delivery, and Qualification Pharma Water Training Course (T23) </div> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.</div> </div> <div class="field field--node-node-link field--name-node-link field--type-ds field--label-hidden field__item"> <a href="/training/course/storage-delivery-qualification-pharma-water" class="button" hreflang="en">View Course</a> </div> </div> </span></div> </div> </div> </li> </ul> </div> </div> </section> <section id="block-socialshareblock" class="block-socialshareblock block block-ispe-social-block block-social-block"> <div class="share-this show-for-large"></div> </section> </div> </section> </main> <aside id="sidebar" class="medium-4 columns" > <div id="sidebar-top" class="sidebar sidebar-top"> <div class="region--sidebar-top region region--sidebar_top"> <section id="block-ispesidebarmenu" class="block-ispesidebarmenu 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