ISPE In Person Training Courses

This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

This classroom or online course has been updated to include the new revised GAMP® 5 Second Edition as well as a fundamental discussion on framing the application of AI/ML in regulated spaces. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements.

This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including  FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.