Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of Risk-Based Cleaning Validation Studies
Instructor:
John Hyde
Product ID: 701184
- Duration: 90 Min
An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.
Areas Covered in the seminar:
- Review of industry current best practices and future trends for cleaning validation studies.
- 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.
- Review of Statistical Process Control (SPC) methodologies for ongoing monitoring of cleaning operations.
Who will benefit::
This webinar will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes, including companies in the Biopharmaceutical, Pharmaceutical and Medical Device fields. The employees who will benefit include:
- Quality Assurance professionals and mangers
- Validation professionals, practitioners and mangers
- Operations professionals and mangers
- Engineering professionals and managers
- Regulatory professionals
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.
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