GAMP® | ISPE | International Society for Pharmaceutical Engineering

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id="left-nav-link-container-desktop"> <template x-for="(entry, index) in entries"> <li> <a @click="selectItem(index)" x-text="entry.text" :class="selectedItemIndex === index && 'bg-blue-150'" class="block py-3 px-6 hover:bg-blue-150"></a> </li> </template> </ol> </nav> </div> </div> </div> </section> </div> <div class="toc-data max-md:px-content-container flex flex-col gap-inter-block overflow-x-hidden px-6 xl:px-0"> <section class="block block-layout-builder block-inline-blockbasic"> <div class="body field field--block-content-body field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="tex2jax_process"><p>GAMP<sup>®</sup> guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve 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.  GAMP® adopts a patient-centric risk-based approach that enables innovation while demonstrating compliance with regulatory requirements. GAMP<sup>®</sup> is an ISPE Community of Practice (CoP). GAMP® provides practical guidance that:</p><div class="m-t-1 m-b-1"><ul><li>- Facilitates the interpretation of regulatory requirements</li><li>- Establishes a common language and terminology</li><li>- Promotes a system life cycle approach based on good practice</li><li>- Clarifies roles and responsibilities</li></ul></div><div class="m-b-1">GAMP<sup>®</sup> guidance does not define a prescriptive method or a standard, but rather provides pragmatic guidance, approaches, and tools for the practitioner.</div><p>The ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems Second Edition aims to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality.  Technological innovation is essential for life sciences industries in providing value to society while also controlling costs and reducing time to market. The Guide facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity, while supporting benefit to public health.<br><a class="button success m-t-1" href="https://ispe.org/initiatives/regulatory/what-gamp">View Other Resources</a></p><p class="m-t-1"><a class="back-to-top js-back-to-top button" href="#">Back to Top</a></p></div></div> </section> </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"> <section class="block block-layout-builder block-inline-blockbasic"> <div class="body field field--block-content-body field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="tex2jax_process"><h2 class="block-title text-gray-700 text-7xl mb-3">GAMP<sup>® </sup>Guidance Documents</h2><p>GAMP® is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training guides for its members. These guidelines are:</p></div></div> </section> <div class="use-tailwind h-full"> <section class="-mt-12 block block-ispe-featured-content block-ispe-featured-content-guidance-documents bg-blue-150 flex flex-col h-full pt-8 px-6"> <div class="" x-data="{ statuses: new Array( ).fill(false), openSection(index) { this.statuses[index] = true; }, closeAllSections() { this.statuses.fill(false); }, toggleSection(index) { const wasClosed = !this.statuses[index]; this.closeAllSections(); if (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"> Artificial Intelligence (1) </h3> <span x-text="statuses[ 0 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 0 ]" 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( 1 )" 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[ 1 ] ? '—' : '+'" 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-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( 2 )" 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[ 2 ] ? 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class="text-blue-800 font-bold leading-6 mb-1">Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/process-analytical-technology"> PAT </a> <a class="tag" href="/topics/pharma-4.0"> Pharma 4.0™ </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-vimeo video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://player.vimeo.com/video/947097762?autoplay=1"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/947097762.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/webinars/videos/aiml-regulated-gxp-life-sciences-sectors-conceptproject-phase-representative-data-sets"> <h5 class="text-blue-800 font-bold leading-6 mb-1">AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/artificial-intelligence"> AI </a> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/gmp"> GMP </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-vimeo video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://player.vimeo.com/video/928567535?autoplay=1"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/928567535.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/webinars/videos/aiml-regulated-gxp-life-sciences-sectors-concept-phase-business-need-risk-assessment"> <h5 class="text-blue-800 font-bold leading-6 mb-1">AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/artificial-intelligence"> AI </a> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/pharma-4.0"> Pharma 4.0™ </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-vimeo video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://player.vimeo.com/video/923510142?autoplay=1"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/923510142.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/webinars/videos/expert-xchange-gampr-implementing-data-integrity-design-0"> <h5 class="text-blue-800 font-bold leading-6 mb-1">ISPE Expert Xchange GAMP®:  Implementing Data Integrity by Design  </h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/data-integrity"> Data Integrity </a> <a class="tag" href="/topics/gamp"> GAMP® </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-vimeo video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://player.vimeo.com/video/923498500?autoplay=1"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/923498500.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/webinars/videos/expert-xchange-gampr-realizing-value-validation-critical-thinking-and-computer-software"> <h5 class="text-blue-800 font-bold leading-6 mb-1">ISPE Expert Xchange GAMP®: Realizing the Value in Validation with Critical Thinking and Computer Software Assurance</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/validation"> Validation </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-youtube video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://www.youtube.com/embed/2jdzdI2CGNw?autoplay=1&amp;start=0&amp;rel=0"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/2jdzdI2CGNw.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/videos/gampr-5-guide-2nd-edition-why-its-needed"> <h5 class="text-blue-800 font-bold leading-6 mb-1">GAMP® 5 Guide, 2nd Edition: Why It's Needed</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/quality-control"> QC </a> <a class="tag" href="/topics/validation"> Validation </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-youtube video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://www.youtube.com/embed/Rg-KjDj8KIs?autoplay=1&amp;start=0&amp;rel=0"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/Rg-KjDj8KIs.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/videos/gampr-5-guide-2nd-edition-whats-news"> <h5 class="text-blue-800 font-bold leading-6 mb-1">GAMP® 5 Guide, 2nd Edition: What's News</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/quality-control"> QC </a> <a class="tag" href="/topics/validation"> Validation </a> </div> </div> </div> </div> <div class="splide__slide"> <div class="h-full "> <div class="mb-4"> <div class="field field--node-field-video field--name-field-video field--type-video-embed-field field--label-hidden field__item"><div data-video-embed-field-lazy="<div class="video-embed-field-provider-youtube video-embed-field-responsive-video"><iframe width="854" height="480" frameborder="0" allowfullscreen="allowfullscreen" src="https://www.youtube.com/embed/fL8gBc4P0og?autoplay=1&amp;start=0&amp;rel=0"></iframe> </div> " class="video-embed-field-lazy"><img src="/sites/default/files/video_thumbnails/fL8gBc4P0og.jpg" alt="" /> <button class="video-embed-field-lazy-play"></button> </div> </div> </div> <div> <div class="text-sm mb-1">Video</div> <a href="/videos/gampr-5-guide-2nd-edition-top-takeaways"> <h5 class="text-blue-800 font-bold leading-6 mb-1">GAMP® 5 Guide, 2nd Edition: Top Takeaways</h5> </a> <div class="tag-container mt-3"> <a class="tag" href="/topics/gamp"> GAMP® </a> <a class="tag" href="/topics/quality-control"> QC </a> <a class="tag" href="/topics/validation"> Validation </a> </div> </div> </div> </div> </div> </div> </div> </div> <a href="/videos" class="flex gap-2 items-center justify-end mt-5"> <span>View All</span> <span><svg width="8" height="13" viewBox="0 0 8 13" fill="none" xmlns="http://www.w3.org/2000/svg"> <path d="M1.00033 1.00103L6.91699 6.48294L1.00033 11.9648" stroke="#0052A5"/> </svg> </span> </a> </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-training-accordion @container bg-gray-50 pt-8 h-full px-6"> <h2 class="block-title text-gray-700 text-3xl @4xl:text-7xl">Professional Development Training</h2> <div class="flex flex-col justify-between h-full" x-data="{ statuses: new Array( 9 ).fill(false), get multipleOrAllSectionsOpen() { const numTotal = this.statuses.length; if (numTotal > 0) { const numOpen = this.statuses.filter(status => status).length; return numOpen === numTotal || numOpen >= 2; } else { return false; } }, toggleSection(index) { this.statuses[index] = !this.statuses[index]; }, toggleAllSections() { if (this.multipleOrAllSectionsOpen) { this.statuses.fill(false); } else { this.statuses.fill(true); } } }" > <div class="flex flex-col h-full"> <button @click="toggleAllSections()" x-text="multipleOrAllSectionsOpen ? '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"> ICH Q8: QbD in Manufacturing </h3> <span x-text="statuses[ 0 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 0 ]" 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 ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/ICH_Q8">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"> A GAMP® Guide to Computerized Systems Compliance </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">Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online 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. 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( 2 )" 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[ 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">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( 3 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> Requirements for Computerized Systems Validation and Compliance </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 describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/requirements-computerized-systems-validation-and-compliance">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"> Cloud Concepts - Cyber Security and Block Chain </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">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( 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. Please click the "Locations and Registrations" table to select the two or three-day sessions.</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/gamp-basic-principles-3-day-training">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 7 )" class="flex justify-between items-center py-3 px-5 cursor-pointer"> <h3 class="font-medium text-black"> GAMP® 5 GxP Process Control Training Course </h3> <span x-text="statuses[ 7 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 7 ]" 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 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> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/gamp-5-gxp-compliance">View Course</a> </div> </div> <div class="bg-white"> <div @click="toggleSection( 8 )" 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, 3-Day Training Course </h3> <span x-text="statuses[ 8 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-700 ml-4"></span> </div> <div x-cloak x-show="statuses[ 8 ]" 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 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> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/gamp-data-integrity-3-day-training">View Course</a> </div> </div> </div> </div> </div> <a href="/training" class="flex gap-2 items-center self-end mb-6"> <span>View All</span> <span><svg width="8" height="13" viewBox="0 0 8 13" fill="none" xmlns="http://www.w3.org/2000/svg"> <path d="M1.00033 1.00103L6.91699 6.48294L1.00033 11.9648" stroke="#0052A5"/> </svg> </span> </a> </div> </section> </div> </div> <div class="second-region flex flex-col gap-12 md:gap-20 lg:gap-26 overflow-x-auto"> <section class="block block-layout-builder block-inline-blockhtml"> <div class="use-tailwind"><div class="@container flex flex-col"> <h4 class="bg-blue-800 text-3xl text-white font-bold py-3.5 px-4"> Pharmaceutical Job Board</h4> <div class="bg-blue-150 overflow-y-auto px-3.5 p-b-2"> <script src="https://jobs.ispe.org/js/widget.min.js?template=default_jobs_widget"></script> </div> </div></div> </section> </div> </div> </div> <div class="use-tailwind"> <div > <div class="main-region tailwind-layout"> <div class="lg:mx-auto flex flex-col gap-12 md:gap-20 lg:gap-26 overflow-x-auto max-w-content-limit-with-padding-compensation px-6 xl:px-0"> <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 class="block eyebrow" datetime="2025-01-01T09:14:14-0500"> 1 January 2025 </time> <a class="block widget-link" href="/pharmaceutical-engineering/january-february-2025">January / February 2025</a> <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">GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…</div> </div> </div> <div class="tag-container pt-1.5"> <a class="tag-white" href="/topics/data-integrity"> Data Integrity </a> <a class="tag-white" href="/topics/gamp"> GAMP® </a> <a class="tag-white" href="/topics/lifecycle-management"> Lifecycle Mgmt </a> </div> </div> <div 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