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.
Why Should You Attend:FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company`s quality management system.
Attend this Webinar to know how to review a company`s Master Validation Plan for major cGMP deficiencies. How to address the FDA`s newer and tougher regulatory stance. How to create a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management and develop meaningful product and process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources. A matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 will be discussed.
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
Note: Use this promocode(
117660) for 10% discount.
