This Cleaning Validation training /webinar will discuss the risk based approach to cleaning validation with reference to ICH Q9.
This session will address risk-based approaches to cleaning validation studies that reduce costs by using ICH Q9 and recent FDA comments and observations as a foundation. Case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.
Areas Covered in the seminar:
- Review of ICH Q9 content with respect to cleaning validation.
- Presentation of practical cleaning validation risk analyses and management tools.
- Review of recent FDA comments and observations on risk-based validation.
- Evaluation of the role of PAT in risk-based cleaning validation studies.
- Case studies - manufacturing facilities.
Who will benefit:
- Quality Assurance professionals and mangers
- Validation professionals, practitioners and mangers
- Operations professionals and mangers
- Engineering professionals and managers
- Regulatory professionals
Instructor Profile:
John Hyde, is the Founder and Chairman of the Board for Hyde Engineering + Consulting, a firm of 80 professionals specializing in providing process systems design, commissioning, validation and FDA compliance services to biopharmaceutical and pharmaceutical manufacturers.
John has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. He has published ten articles on these subjects.
