Management | ISPE | International Society for Pharmaceutical Engineering

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'—' : '+'" 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/good-practice-guide-operations-management">Good Practice Guide: Operations Management</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"> Drug Shortages (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/cultural-excellence-report-six-key-dimensions">The Cultural Excellence Report - Six Key Dimensions</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"> Investigational Products (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/good-practice-guide-clinical-supply-systems">Good Practice Guide: Clinical Supply Systems</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"> Knowledge Management (4) </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/good-practice-guide-knowledge-management-pharmaceutical-industry">Good Practice Guide: Knowledge Management in Pharmaceutical Industry</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/apq-guide-cultural-excellence">APQ Guide: Cultural Excellence</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/apq-guide-process-performance-product-quality-monitoring-system-pppqms">APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/apq-guide-management-responsibilities-review-mrr">APQ Guide: Management Responsibilities & Review (MRR)</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"> Lifecycle Management (1) </h3> <span x-text="statuses[ 4 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 4 ]" 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/apq-guide-process-performance-product-quality-monitoring-system-pppqms">APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 5 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Process Analytical Technology (1) </h3> <span x-text="statuses[ 5 ] ? '—' : '+'" 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/apq-guide-process-performance-product-quality-monitoring-system-pppqms">APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)</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"> Project Management (6) </h3> <span x-text="statuses[ 6 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 6 ]" 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/good-practice-guide-technology-transfer-3rd-edition">Good Practice Guide: Technology Transfer 3rd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/good-practice-guide-operations-management">Good Practice Guide: Operations Management</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/project-management-pharmaceutical-industry">Good Practice Guide: Project Management for the Pharmaceutical Industry</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/good-practice-guide-good-engineering-practice-2nd-edition">Good Practice Guide: Good Engineering Practice 2nd Edition</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/good-practice-guide-management-engineering-standards">Good Practice Guide: Management of Engineering Standards</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/cultural-excellence-report-six-key-dimensions">The Cultural Excellence Report - Six Key Dimensions</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 7 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Quality Assurance (3) </h3> <span x-text="statuses[ 7 ] ? '—' : '+'" class="font-bold text-3xl leading-5 text-gray-650 ml-4"></span> </div> <ul x-cloak x-show="statuses[ 7 ]" 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/apq-guide-cultural-excellence">APQ Guide: Cultural Excellence</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/apq-guide-management-responsibilities-review-mrr">APQ Guide: Management Responsibilities & Review (MRR)</a> </li> <li class="pl-2"> <a href="/publications/guidance-documents/cultural-excellence-report-six-key-dimensions">The Cultural Excellence Report - Six Key Dimensions</a> </li> </ul> </div> <div class="bg-white"> <div @click="toggleSection( 8 )" class="flex justify-between py-3 px-5 cursor-pointer"> <h3 class="font-bold text-gray-700"> Supply Chain Management (1) </h3> <span x-text="statuses[ 8 ] ? 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</div> </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-recent-content"> <h2 class="block-title text-gray-700 text-3xl md:text-7xl -mb-7">Pharmaceutical Engineering Magazine Articles </h2> <div class="use-tailwind"> <div data-ispe-slider> <div class="splide" data-splide='{ "fixedWidth": "min(17.25rem, 92vw)", "gap": "1.25rem", "type": "loop" }'> <div class="splide__arrows flex justify-end gap-2 lg:gap-3 mt-1 mb-3 md:mt-0 md:mb-4 "> <button class="splide__arrow--prev"> <img src="/themes/custom/ispe/images/control-arm-left-mobile.svg" alt="Previous" class="lg:hidden"/> <img src="/themes/custom/ispe/images/control-arm-left-desktop.svg" alt="Previous" class="hidden lg:inline"/> </button> 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src="/sites/default/files/styles/teaser_image/public/2025-03/0325_PE_MA_DeVivo_v2.jpg?itok=-O5RFVPt" width="1000" height="600" alt="Process Architecture and Integrated Design in the Pharmaceutical Sector" /> </a> </div> </div> <div> <a href="/pharmaceutical-engineering/march-april-2025/process-architecture-and-integrated-design"> <h5 class="text-blue-800 font-bold leading-6 mb-1">Process Architecture and Integrated Design in the Pharmaceutical Sector</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">Large engineering companies specializing in the industrial production sector have increasingly been…</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 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Culture</a> <div></div> <div class="tag-container pt-1.5"> <a class="tag-white" href="/topics/quality-control"> QC </a> <a class="tag-white" href="/regulatory"> Regulatory </a> </div> </div> <div class="space-y-1.5"> <a class="block widget-link" href="/initiatives/pharma-4.0">Pharma 4.0™</a> <div></div> </div> <div class="space-y-1.5"> <a class="block widget-link" href="/women-pharma">Women in Pharma®</a> <div></div> </div> <div class="space-y-1.5"> <a class="block widget-link" href="/initiatives/pqli">Product Quality Lifecycle Implementation (PQLI) ®</a> <div></div> <div class="tag-container pt-1.5"> <a class="tag-white" href="/topics/lifecycle-management"> Lifecycle Mgmt </a> <a class="tag-white" href="/regulatory"> Regulatory </a> </div> </div> <div class="space-y-1.5"> <a class="block widget-link" href="/initiatives/advancing-pharmaceutical-quality">Advancing Pharmaceutical Quality™</a> <div></div> <div class="tag-container pt-1.5"> <a class="tag-white" href="/topics/quality-assurance"> QA </a> <a class="tag-white" href="/regulatory"> Regulatory </a> </div> </div> </div> <a href="/initiatives/regulatory" class="flex gap-2 items-center grow-0 self-end mt-4"> <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> <img class="hidden @4xl:block self-center object-cover py-4" src="/themes/custom/ispe/images/laptop-video-conference.png" alt="Video conference on laptop"> </div> </section> </div> </div> </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-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( 5 ).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"> Good Engineering Practice (GEP) Training Course </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">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…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/good-engineering-practice-gep">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"> ICH Q10: Pharmaceutical Quality System (PQS) </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 Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/ICH_Q10">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"> GxPs for Leadership </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">This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/gxps-leadership">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"> Advancing Pharmaceutical Quality™ (APQ) Quality Management Maturity Training Course </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">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> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/course/apq-quality-management-maturity-training-course">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"> GMP Fundamentals: Organization and Personnel </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">The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuous basis and with sufficient frequency to ensure that employees…</div> </div> </span> <a class="bg-purple-800 text-white uppercase w-max py-3 px-6" href="/training/online-learning/gmp-fundamentals-organization-personnel">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 class="use-tailwind h-full"> <section class="block block-ispe-featured-content block-ispe-featured-content-recent-content"> <h2 class="block-title text-gray-700 text-3xl md:text-7xl -mb-7">Videos</h2> <div class="use-tailwind"> <div data-ispe-slider> <div class="splide" data-splide='{ "fixedWidth": 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<time datetime="2025-05-14T17:00:00-0400">14 May 2025</time> </div> <div class="text-sm mb-2 mt-2"> <span>London</span>, <span></span> <span>GB</span> </div> </div> </div> <div class="splide__slide relative bg-gray-50 lg:bg-blue-150 p-3"> <div> <h2> <a class="text-blue-800 font-bold leading-6 mb-1 mt-2" href="/conferences/2025-ispe-biotechnology-conference">2025 ISPE Biotechnology Conference</a> </h2> <div class="text-sm mb-2 mt-3"> <time datetime="2025-06-02T08:00:00-0400">02</time> - <time datetime="2025-06-03T18:00:00-0400">3 June 2025</time> </div> <div class="text-sm mb-2 mt-2"> <span>Boston</span>, <span>MA</span> <span>US</span> </div> </div> </div> <div class="splide__slide relative bg-gray-50 lg:bg-blue-150 p-3"> <div> <h2> <a class="text-blue-800 font-bold leading-6 mb-1 mt-2" href="/conferences/2025-pharma-40-conference">2025 ISPE Pharma 4.0™ Conference</a> </h2> <div class="text-sm mb-2 mt-3"> <time datetime="2025-12-09T08:00:00-0500">09</time> - <time datetime="2025-12-10T18:00:00-0500">10 December 2025</time> </div> <div class="text-sm mb-2 mt-2"> <span>Barcelona</span>, <span>Spain</span> <span>ES</span> </div> </div> </div> <div class="splide__slide relative bg-gray-50 lg:bg-blue-150 p-3"> <div> <h2> <a class="text-blue-800 font-bold leading-6 mb-1 mt-2" href="/conferences/2026-ispe-facilities-future-conference">2026 ISPE Facilities of the Future Conference</a> </h2> <div class="text-sm mb-2 mt-3"> <time datetime="2026-02-02T08:00:00-0500">02</time> - <time datetime="2026-02-03T17:00:00-0500">3 February 2026</time> </div> <div class="text-sm mb-2 mt-2"> <span>San Diego</span>, <span>CA</span> <span>US</span> </div> </div> </div> </div> </div> </div> </div> <a href="/conferences" class="flex gap-2 items-center justify-end"> <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> 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