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The Master Validation Plan – The Unwritten Requirements

 
  October 12, 2020  
     
 


Webinar Compliance, Online Event
2020-11-17


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 You Should 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.

Areas Covered in the Session :

 

  • 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
Who Should Attend:

 

  • Quality Departments
  • Regulatory Affairs Departments
  • R&D Departments
  • Engineering Departments
  • Production Departments
  • Operations Departments
  • Consultants

MD258

4

 
 
Organized by: Compliance Trainings
Invited Speakers:

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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.

 
Deadline for Abstracts: Register on or before November 15 2020
 
Registration:

Duration - 90 minutes
 
Single Live - $200.00 
E-mail: support@compliancetrainings.com
 
 
   
 
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