FDA Warning Letters and recalls indicate major cGMP deficiencies in big name device and pharma companies, many centered around master / discrete V&V planning and execution.  What is V&V planning.  What really is a Master Validation Plan? Why do companies need one?   What is the discrete / individual V&V plan? It’s format and key components? What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management?  How can these be integrated?   What are the differences and similarities between Product, Equipment (production and lab/test), Process, and QMS V&V? Examples of specific, targeted Test Cases for each subject and each qualification (IQ, OQ, and PQ).  Software / firmware V&V consideration and integration into the plans / protocols. All information and formats have decades of field testing with the US FDA and EU Notified Bodies.

Course Objectives:

What is Verification?  Validation?   Pharma.  Medical Devices.  Review the company Validation Master  Plan for purpose and content.  Address the FDA's newer and tougher regulatory stance on V&V.  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.  The  different validation 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 also discussed.  The information provided will allow the project leader to develop key milestones / tasks for a successful V&V project, that have cleared FDA and Notified Body review.

Why Should You Attend:

Both the U.S. FDA CGMPs and Guidance Documents  and EU's MDD/MDR and standards require documented risk-based "master" and "individual" V&V planning and execution with clearly documented Test Reports / Protocols.

Course Outline:

• Verification or Validation – what is it in a real-world environment?
• Recent regulatory expectations.
• The Master Validation Plan.
• The Individual V&V Plan
• “Working” definitions.
• DQ, IQ, OQ, PQ, ASTM E2500 Equivalents – Definitions, formats, example test cases.
• Using the Risk Management tools of ISO 14971 and ICH Q9
• Product, Process.  Equipment (production, test, lab)  Test Report structure and content.
• Proven trouble spots and their resolution.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior and Middle Management
• Validation engineers / teams
• Marketing
• QA/RA
• Supervisors
• R&D
• Manufacturing Engineering
• Software Engineering
• Operations
• Consultants