Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. One major failing is lack of sufficient or targeted risk-based V&V planning. But a review of Internet forums shows confusion as to what is V&V planning.
What really is a Master Validation Plan?
Why do companies need one?
What is the individual V&V plan and its high value.
What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management?
How can these be integrated?
Software / firmware V&V?
Review a company's Validation Master Plan for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Validation Master Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product and process validations. Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Our 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 are considered.
Areas Covered in the Webinar:
Verification or Validation - Recent regulatory expectations
The Master Validation Plan
The Individual V&V Plan
Product V&V versus Process / Equipment V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Using the Risk Management tools of ISO 14971 and ICH Q9
The 11 Elements of the Software VT&V "Model"
Key recent compliance problems
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. One major failing is lack of sufficient or targeted risk-based V&V planning. But a review of Internet forums shows confusion as to what is V&V planning.
What really is a Master Validation Plan?
Why do companies need one?
What is the individual V&V plan and its high value.
What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management?
How can these be integrated?
Software / firmware V&V?
Review a company's Validation Master Plan for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Validation Master Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product and process validations. Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Our 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 are considered.
Areas Covered in the Webinar:
Verification or Validation - Recent regulatory expectations
The Master Validation Plan
The Individual V&V Plan
Product V&V versus Process / Equipment V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Using the Risk Management tools of ISO 14971 and ICH Q9
The 11 Elements of the Software VT&V "Model"
Key recent compliance problems