Webinars

These recorded sessions span 10 topics pertinent to global pharmaceutical manufacturing professionals. Find case studies with in-depth knowledge, best practices from top-notch seminars and authors of ISPE Guidance Documents.

Course Modules/Learning Objectives

• Active Pharmaceutical Ingredients
  • Product Quality Lifecycle Implementation (PQLI®): Focusing on Q10
  • Product Quality Lifecycle Implementation (PQLI®): Vision, Status and Next Steps
  • ICH Q11: Development and Manufacture of Drug Substances Status, Challenges, and Expectations
• Biotechnology
  • Biotechnology Basics: Fundamental Principles of the Biotechnology
  • Understanding Process Validation in Biotechnology Manufacturering
  • Biopharmaceutical Manufacturing Processes
  • Biopharmaceutical Manufacturing Facilities
  • Development and Qualification of a Robust Cold Chain Logistics Solution for Bulk Biologics
• Commissioning and Qualification
  • ICH Q9 Quality Risk Management
  • Science and Risk Based C&Q Approach (Recorded)
  • FDA Process Validation Guidance: A Review with Implications for C&Q
  • Risk-based Verification of Facilities, Systems and Equipment Workshop
  • Implementing ASTM Standard for Verification (C&Q)
• Containment
  • Containment Fundamentals
• Good Automated Manufacturing Practices
  • A Risk-Based Approach to Regulated Mobile Apps
  • Life After GAMP 5: What Comes Next?
  • The Impact of GCP Guidance and the Importance of GAMP
  • Manufacturing Execution Systems (MES) GPG: Are you On-Board?
  • A GAMP Interpretation - Annex 11
  • GAMP® 5 Series: Managing Quality in an Outsourced Environment
  • GAMP® 5 Series: IT Infrastructure Compliance and Control
  • GAMP® 5: End-User Applications
  • GAMP® 5 Series: Changing the Industry
  • Official GAMP Interpretation - Annex 11
  • New Revised EU GMP Annex 11
• Process Analytical Technology
  • Introduction to Process Analytical Technology
• Product Process Development
  • The ISPE Quality Metrics Initiative
  • The ISPE Drug Shortages Initiative
  • Industry Overview: Drug Dosage Forms
  • FDA Process Validation Guidance: A Review with Implications
• Project Management
  • Facing the China Challenge: Construction Projects in China
  • Delivering Manufacturing Projects in a Risk-based World: The New Regulatory Paradigm and its Impact on Facility Design
  • Benchmarking to Manage Risk
  • Excellence by Design: Integrating Safety into Project Design Review
• Heating, Ventilation, and Air Conditioning
  • HVAC and Utilities: Special Requirements
  • HVAC: Practical Guidance for GMP Facilities
• Operations Management
  • Facing the China Challenge: Construction Projects in China

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