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The Master Validation Plan – The Unwritten Requirements

5319
Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more


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 company-wide V&V planning.

Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must also be considered.

Why Should You Attend:

Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased.

Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.

Course Outline:

• Verification or Validation – Recent regulatory expectations

• The Master Validation Plan and its structure

• Product Validation – how it differs from process / equipment V&V

• Process / Equipment / Facility Validation – including FDA’s recent guidance

• When and How to use DQ, IQ, OQ, PQ, or their equivalents

• How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)

• The 11 key documents for software validation

• Incorporating 21 CFR Part 11 requirements

• Suggested “test case” formats

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Quality Departments

• Regulatory Affairs Departments

• R&D Departments

• Engineering Departments

• Production Departments

• Operations Departments

• Consultants

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : The Master Validation Plan – The Unwritten Requirements


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