Information Systems | ISPE | International Society for Pharmaceutical Engineering

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(wasClosed) { this.openSection(index); } } }" > <div class="grid grid-cols-2-l-2 gap-3 max-h-96 overflow-y-auto"> <div class="bg-blue-800"></div> <div class="flex flex-col gap-3"> <div class="bg-white"> <div @click="toggleSection( 0 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Advanced Manufacturing (1) </h3> <span x-text="statuses[ 0 ] ? 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'—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 1 ]" class="list-square list-outside marker:text-blue-800 space-y-3 mb-3 ml-8 mr-4"> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-5-guide-2nd-edition">GAMP 5 Guide 2nd Edition</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 2 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Commissioning & Qualification (1) </h3> <span x-text="statuses[ 2 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 2 ]" class="list-square list-outside marker:text-blue-800 space-y-3 mb-3 ml-8 mr-4"> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-testing-gxp-systems-2nd-edition">GAMP Good Practice Guide: Testing GxP Systems 2nd Edition</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 3 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Data Integrity (15) </h3> <span x-text="statuses[ 3 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 3 ]" class="list-square list-outside marker:text-blue-800 space-y-3 mb-3 ml-8 mr-4"> <li class="pl-2"> <a href="/publications/guidance-documents/baseline-guide-vol-8-pharma-40-1st-edition">Baseline Guide Vol 8: Pharma 4.0 1st Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-gxp-process-control-systems">GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-records-pharmaceutical-data-integrity">GAMP Guide: Records & Data Integrity</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-global-information-systems-compliance">GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-date-integrity-key-concepts">GAMP RDI Good Practice Guide: Data Integrity - Key Concepts</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-data-integrity-manufacturing-records">ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-calibration-management">GAMP Good Practice Guide: Calibration Management 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-rdi-good-practice-guide-data-integrity-design">GAMP RDI Good Practice Guide: Data Integrity by Design</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-gxp-computerized-systems">GAMP Good Practice Guide: Operation of GxP Computerized Systems</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-5-guide-2nd-edition">GAMP 5 Guide 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-enabling-innovation">GAMP Good Practice Guide: Enabling Innovation</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-testing-gxp-systems-2nd-edition">GAMP Good Practice Guide: Testing GxP Systems 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-regulated-mobile-applications">GAMP Good Practice Guide: Regulated Mobile Applications</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-it-infrastructure-control-compliance">GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-good-practice-guide-gxp-compliant-laboratory-computerized-systems">GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 4 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> GAMP® (14) </h3> <span x-text="statuses[ 4 ] ? 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'—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 5 ]" class="list-square list-outside marker:text-blue-800 space-y-3 mb-3 ml-8 mr-4"> <li class="pl-2"> <a href="/publications/guidance-documents/gamp-rdi-good-practice-guide-data-integrity-design">GAMP RDI Good Practice Guide: Data Integrity by Design</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 6 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Pharma 4.0™ (1) </h3> <span x-text="statuses[ 6 ] ? 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A chartered…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/january-february-2025/celebrating-25-years-gampr-americas" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2025-01/PatientSafety.jpg?itok=qKWMO_2q" width="1000" height="600" alt="Celebrating 25 Years of GAMP® Americas" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/january-february-2025/celebrating-25-years-gampr-americas"> <h5 class="text-blue-800 font-bold leading-6 mb-1">Celebrating 25 Years of GAMP® Americas</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">This special anniversary article addresses the history and milestones that define the GAMP Community…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/january-february-2025/removing-frustration-functional-risk-management" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2025-01/RiskAssessment.jpg?itok=84r43POM" width="1000" height="600" alt="Removing the Frustration from Functional Risk Management" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/january-february-2025/removing-frustration-functional-risk-management"> <h5 class="text-blue-800 font-bold leading-6 mb-1">Removing the Frustration from Functional Risk Management</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/january-february-2025/gampr-approach-computerized-system-life-cycle-and" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2025-01/0125_PE_JF_Wyn_01.jpg?itok=CdDcVDWk" width="1000" height="600" alt="A GAMP® Approach to Computerized System Life Cycle and IT Process Records" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/january-february-2025/gampr-approach-computerized-system-life-cycle-and"> <h5 class="text-blue-800 font-bold leading-6 mb-1">A GAMP® Approach to Computerized System Life Cycle and IT Process Records</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">This article describes a practical and pragmatic approach to the management of computerized system…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/updated-gamp-gpg-incorporates-ai-and-open-source-software" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2025-01/0125_PE_JF_Cover_01.jpg?itok=lWsJz3Ci" width="1000" height="600" alt="Updated GAMP® GPG Incorporates AI and Open-Source Software" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/updated-gamp-gpg-incorporates-ai-and-open-source-software"> <h5 class="text-blue-800 font-bold leading-6 mb-1">Updated GAMP® GPG Incorporates AI and Open-Source Software</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/pharmaceutical-engineeringr-article-wins-2024" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_11.jpg?itok=p_lMy6e9" width="1000" height="600" alt="Pharmaceutical Engineering® Article Wins 2024 APEX Award" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/november-december-2024/pharmaceutical-engineeringr-article-wins-2024"> <h5 class="text-blue-800 font-bold leading-6 mb-1">Pharmaceutical Engineering® Article Wins 2024 APEX Award</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">ISPE has been honored with a 2024 APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other…</div> </div> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-ispe-air" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_01_0.jpg?itok=oan_5uv-" width="1000" height="600" alt="ISPE AI®" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-ispe-air"> <h5 class="text-blue-800 font-bold leading-6 mb-1">ISPE Announces ISPE AI®</h5> </a> <div> <div class="field field--node-field-description field--name-field-description field--type-text-long field--label-hidden field__item"> <div class="tex2jax_process">ISPE recently announced ISPE AI ®, an initiative aimed at aiding the pharmaceutical industry in…</div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </section> </div> </div> </div> </div> </div> <div class="use-tailwind"> <div class="tailwind-layout max-w-content-limit-with-padding-compensation lg:mx-auto grid gap-6 max-md:grid-rows-auto md:grid-cols-2-67/33 lg:grid-cols-2-75/25 px-6 xl:px-0"> <div class="first-region flex flex-col gap-12 md:gap-20 lg:gap-26 overflow-x-auto"> <div class="use-tailwind h-full"> <section class="block block-ispe-featured-content block-ispe-featured-content-concept-and-discussion-papers @container bg-blue-150 flex flex-col pt-8 pb-4 h-full px-6"> <h2 class="block-title text-gray-700 text-7xl mb-6">White Papers</h2> <div class="@4xl:grid @4xl:grid-cols-2-r-100 @4xl:gap-8 h-full"> <div class="flex flex-col justify-between h-full"> <div class="flex flex-col gap-8 pb-2"> <div class="space-y-1.5"> <time 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'Collapse All' : 'Expand All'" class="self-end text-blue-800 cursor-pointer mt-3 @4xl:mt-5"></button> <div class="grid grid-cols-2-l-2 gap-3 pb-9 mt-4"> <div class="bg-cyan-700"> </div> <div class="flex flex-col gap-3"> <div class="bg-white"> <div @click="toggleSection( 0 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> A GAMP® Guide to Computerized Systems Compliance </h3> <span x-text="statuses[ 0 ] ? 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Course Modules…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/gamp-guide-computerized-systems-compliance">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 1 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course </h3> <span x-text="statuses[ 1 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 1 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <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…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/gamp-data-integrity-2-day-training">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 2 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> GMP Fundamentals: Quality System </h3> <span x-text="statuses[ 2 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 2 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <div class="body field field--node-body field--name-body field--type-text-with-summary field--label-hidden field__item"> <div class="tex2jax_process">To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work together, and establishes performance specifications. The Quality System provides mechanisms to monitor and control processes, systems, and people to ensure the highest level of safety, quality, and efficacy. In this On Demand course (part 3 of 11), you will learn the elements of a Quality System, as…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/gmp-fundamentals-quality-system">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 3 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> Cloud Concepts - Cyber Security and Block Chain </h3> <span x-text="statuses[ 3 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 3 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <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 online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of regulatory compliance will be explored and answers on how one can comply will be provided. If already operating in the cloud, attendees will be gain insight on how they can assess their own company's cloud platform, and take proactive measures to resolve any vulnerabilities.</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/cloud-concepts-cyber-security-block-chain">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 4 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> Quality Management Systems Training Course </h3> <span x-text="statuses[ 4 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 4 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <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> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/quality-management-systems-agile-approach-product-realization-lifecycle">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 5 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> GAMP® Basic Principles 2-Day Training Course </h3> <span x-text="statuses[ 5 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 5 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <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> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/gamp-basic-principles-2-day-training-course">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 6 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> GAMP® Basic Principles 3-Day Training Course </h3> <span x-text="statuses[ 6 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 6 ]" class="flex flex-col gap-8 pt-2 pb-5 px-5"> <span> <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. 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