The Best Way to Develop or Improve a Master Validation Plan

    /John E.   /Lincolnspeaker of compliance global
    Speaker: John E. Lincoln
    Duration: 90 Minutes
    Product Code: 700015
    Level: Intermediate
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overview

How to develop or improve upon a Master Validation Plan / Validation Master Plan or System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.

FDA Warning Letters and recent high-profile recalls indicate major cGMP regulations deficiencies in many companies.

One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.  Starting with a Validation Master Plan, evaluating its elements against ISO 14971 process hazard analysis / risk management plan, 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, cannot be analyzed as to inventory impact, do not consider allowable “worst case” inputs, 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.

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Areas Covered

  • 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
  • Putting it all together

Learning Objectives

  • Sort through all the differing theories, outright misstatements on Internet forums and understand a field-proven system.
  • Understand the unstated regulatory requirements for a MVP/ VMP.
  • The nature and structure of the VMP document(s).
  • How the VMP feeds the individual Validation Plan.
  • Know the similarities and differences in:
  1. Product V&V
  2. Process V&V
  3. Equipment V&V
  4. Software / Firmware V&V – In-product, As-product,
  5. Equipment, and ERP / QMS
  6. Be able to define, structure and resource a corporate and satellite / plant V&V system(s).

WHO WILL BENEFIT

  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA/RA Professionals
  • R&D Professionals
  • Engineering Professionals
  • Operations Professionals
  • Manufacturing Professionals
  • Document Control Professionals

SPEAKER

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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