Content focuses on the role and elements of a quality management system, its impact on the overall risk management approach, and its implementation scientifically and pragmatically. Case studies could demonstrate risk management's purpose, elements, and implementation, a quality management system, and systems validation.
Guidance Documents
Artificial Intelligence (1)
+Biotechnology (1)
+Commissioning & Qualification (5)
+Compounding (1)
+Containment (1)
+Data Integrity (16)
+Drug Shortages (1)
+GAMP® (15)
+Good Manufacturing Practice (1)
+Knowledge Management (6)
+Lifecycle Management (3)
+Manufacturing Operations (2)
+Microbiological & Viral Contamination Control (3)
+Pharma 4.0™ (1)
+Process Analytical Technology (5)
+Project Management (1)
+Quality Assurance (9)
+Quality Control (1)
+Quality by Design (5)
+Regulatory (4)
+Sustainable Facilities, HVAC, & Controlled Environments (2)
+Validation (14)
+Community Discussions
Community Discussions
Jul 22, 2025
Data Integrity
Jul 17, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
Pharmaceutical Engineering Magazine Articles
Webinars
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ISPE in the News
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Double Your Impact: ISPE Join/Renew Offer
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New Certificate Programs from ISPE Academy
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Automated Drug Discovery Facility Opens in Scotland
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US FDA Seeks Comments on Draft Guidance for Cancer Drug Combinations
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Lupin API Plant Earns GMP Certification from Australia's TGA
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Moderna Shelves Plan for mRNA Plant in Japan
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GenesisM Starts Work on Biomanufacturing Facility in Massachusetts
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Overcoming Barriers to Advanced Manufacturing
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Experts Discuss Pharma Supply Chain Resilience
- ISPE Webinar: Life Cycle Approach to Process Validation - Stage 3 Implementation
White Papers
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
