+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Validation Master Plan - The Unwritten Requirements - Webinar

  • ID: 4899816
  • Webinar
  • December 2018
  • Region: Global
  • 120 Minutes
  • Compliance Online
1 of 2
Why Should You Attend:

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.

Areas Covered in the Webinar:

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
Note: Product cover images may vary from those shown
2 of 2

Loading
LOADING...

3 of 2
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.
Note: Product cover images may vary from those shown
Adroll
adroll