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)
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+Commissioning & Qualification (5)
+Compounding (1)
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+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)
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+Sustainable Facilities, HVAC, & Controlled Environments (2)
+Validation (14)
+Community Discussions
Community Discussions
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Pharmaceutical Engineering Magazine Articles
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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Navigating Innovation: The United Kingdom's (UK) Evolving Regulatory Landscape
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ISPE Training: Storage, Delivery, and Qualification Pharma Water, Online Live, 22-23 July
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ISPE SmartBrief will not be published July 4
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Startup Produces Recombinant Proteins with Silkworms
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Iraq Sets Pharmaceutical Production Goal
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AbbVie to Acquire CAR T Therapy Developer for $2.1B
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U of Okla. Opens Bioprocessing Training Facility
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Aenova Builds Refrigerated Warehouse in Latina, Italy
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Risk-based Cleaning Process Qualification Minimizes Samples, Runs
- Sigachi Pharma Chemicals Plant in Telangana, India, Catches Fire
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…
