Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

In this V & V planning training Webinar learn to create a Master Validation plan, evaluate its elements against ISO 14971, ICH Q9 for hazard analysis and Risk management. How to employ DQs, IQs, OQs and PQs.
Areas Covered in the Seminar :

  • Verification or Validation -- Recent regulatory expectations.
  • The Master Validation Plan.
  • Product V&V versus Process / Equipment V&V.
  • When and How to Use DQ, IQ, OQ, PQ.
  • Using the Risk Management tools of ISO 14971 and ICH Q9.
  • The 11 Elements of the Software VT&V "Model".
  • Avoid recent "horror stories" and multimillion dollar fines.

Who Will Benefit :
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering, including Software
  • All personnel involved in verification and/or validation planning, execution and documentation

For Registration:
Note: Use this promocode(117660) for 10% discount.