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Browse By Topic Join/Renew Login Connecting Pharmaceutical Knowledge Menu Join/Renew Login Main navigation Conferences & Training Conferences Upcoming Call for Proposals Training Custom Onsite Hands-On Training In Person On Demand Online Live Webinars Live Library Events Calendar Exhibits & Sponsorships Membership & Communities Membership Volunteer Opportunities Communities of Practice ISPE Engage Forums Affiliates and Chapters Women in Pharma Emerging Leaders Students Pharmaceutical Job Board Publications Guidance Documents Guidance Documents Portal Pharmaceutical Engineering Magazine iSpeak Blog Concept & Discussion Papers Glossary Programs Facility of the Year Awards Foundation International Honor Awards Pharma 4.0 Regulatory & Initiatives About ISPE About ISPE Leadership Videos News Careers at ISPE Corporate Partners Advertising & Sponsorships Secondary Menu - Occupational Facilities & Equipment Information Systems Management Product Development Quality Regulatory Supply Chain PE Magazine | March / April 2024 A Sustainable Approach to Steam Quality Management The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. Read More iSpeak Blog | 17 April 2024 Lean Stability Strategies and Best Practices Discussed during Webinar Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. Read More iSpeak Blog | 5 April 2024 Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Read More Guidance Documents 75+ documents available Community Forums 100+ discussions happening Women in Pharma® International Womens Day #InspireInclusion ISPE Highlights Video Attend the 2024 ISPE Biotechnology Conference iSpeak Blog Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals. iSpeak Blog Emerging Leader Hacker to GAMPer in 10 Weeks iSpeak Blog Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization iSpeak Blog Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future iSpeak Blog Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor iSpeak Blog Quality Management Maturity: The Strategic Vision for Biopharmaceutical Excellence Video ISPE Strategic Plan Summary iSpeak Blog Lean Stability Strategies and Best Practices Discussed during Webinar Product Guide: 503A Compounding iSpeak Blog Highlights from the 2024 ISPE Aseptic Conference iSpeak Blog Challenges and Trends in Biopharmaceutical Facility Design Pharmaceutical Engineering Magazine Meet the ISPE Staff: Matt Lehmann 2024 ISPE Facilities of the Future Conference: Keynote Presentations 2024 ISPE Biotechnology Conference Q&A Pharma 4.0™ Plug and Produce Working Group Publishes Concept Papers New Guides Expand ATMP Knowledge Key Findings from the 2023 C&Q Baseline® Guide Survey Volunteer Leader Profile: Containment CoP Chair Glenn Lawrence, PE Volunteer Leader Profile: Biotechnology CoP Co-Chair Laura-Ann Chin, PE Frances Zipp Receives 2023 Professional Achievement Award Quality Risk Management for Biopharmaceuticals Cell Culture Media Manufacturing Controls for Bio-Manufacturing Building Better Therapies With Antibody Engineering View All Guidance Documents Guides Guide: 503A Compounding Guides Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt Guides Guide: ATMPs - Allogeneic Cell Therapy Baseline Guides Baseline Guide Vol 8: Pharma 4.0 1st Edition Baseline Guides Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition Good Practice Guides Good Practice Guide: Process Gases 2nd Edition Guides Guide: 503B Compounding Good Practice Guides Good Practice Guide: Containment for Potent Compounds APQ APQ Guide: Cultural Excellence APQ APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS) GAMP GAMP 5 Guide 2nd Edition APQ APQ Guide: Change Management (CM) System View All Regulatory Initiatives Quality Culture QC Regulatory Product Quality Lifecycle Implementation (PQLI) ® Lifcyc Mgmt Regulatory Advancing Pharmaceutical Quality QA Regulatory View All Highlights From ISPE Knowledge Network Explore webinars, training PE articles, and more relevant to your job function. These top focus areas bring the most relevant ISPE content to the forefront of your browsing experience. Explore webinars, training, PE articles and more. Facilities & Equipment Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals. May / June 2024 Guide: 503A Compounding Highlights from the 2024 ISPE Aseptic Conference View Related Content Information Systems Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization Highlights from the 2024 ISPE Aseptic Conference Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering What you need to know about the GAMP track: 2024 ISPE Europe Annual Conference, 16 – 18 April View Related Content Management GxPs for Leadership Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future Lean Stability Strategies and Best Practices Discussed during Webinar Highlights from the 2024 ISPE Aseptic Conference View Related Content Product Development Attend the 2024 ISPE Biotechnology Conference May / June 2024 Highlights from the 2024 ISPE Aseptic Conference Understanding the Challenges in Drug Shortages View Related Content Quality Attend the 2024 ISPE Biotechnology Conference May / June 2024 GxPs for Leadership Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization View Related Content Regulatory Highlights from the 2024 ISPE Aseptic Conference GMP Refresher March / April 2024 Practical Applications of Current Standards and Regulations in the Context of Digitalization View Related Content Supply Chain Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals. Highlights from the 2024 ISPE Aseptic Conference Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering March / April 2024 View Related Content Facilities & Equipment Information Systems Management Product Development Quality Regulatory Supply Chain Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals. May / June 2024 Guide: 503A Compounding Highlights from the 2024 ISPE Aseptic Conference View Related Content Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization Highlights from the 2024 ISPE Aseptic Conference Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering What you need to know about the GAMP track: 2024 ISPE Europe Annual Conference, 16 – 18 April View Related Content GxPs for Leadership Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future Lean Stability Strategies and Best Practices Discussed during Webinar Highlights from the 2024 ISPE Aseptic Conference View Related Content Attend the 2024 ISPE Biotechnology Conference May / June 2024 Highlights from the 2024 ISPE Aseptic Conference Understanding the Challenges in Drug Shortages View Related Content Attend the 2024 ISPE Biotechnology Conference May / June 2024 GxPs for Leadership Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization View Related Content Highlights from the 2024 ISPE...