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Ref : 30274
Event :Validation Master Plan - The Unwritten Requirements

Date :Wednesday November 20th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
 

Objectives

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.

Program

  • 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

Speakers

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln 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. Mr. Lincoln is a graduate of UCLA.

 

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Validation Master Plan - The Unwritten Requirements Management
validation master plan, validation master plan fda, validation master plan guidelines, elements of master validation plan, cgmp deficiencies, v&v planning, equipment v&v
Professionals, Senior management Regulatory Affairs Quality Assurance Production Engineering, Including Software All personnel involved in verification and/or validation planning, Execution and documentation.
10 -- --
English

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