Validation Master Planning - The Unstated Requirements

Speaker

Instructor: John E Lincoln
Product ID: 704292

Location
  • Duration: 90 Min
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
RECORDED TRAINING
Last Recorded Date: Nov-2015

 

$279.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Fax: +1-650-362-2367

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Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems / documents? What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's QMS?

This webinar training will review a company's Master Validation Plan or Validation Master Plan for major cGMP deficiencies. It will 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 roles of different V&V 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 as well.

Areas Covered in the Webinar:

  • Verification or Validation - Recent Regulatory Expectations
  • The Validation Master 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
  • Avoid Recent Compliance Problems

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on medical devices, its principles apply to personnel / companies in the pharmaceutical, diagnostic, and biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory affairs
  • Quality assurance
  • Production
  • Engineering including software
  • All personnel involved in verification and/or validation planning, execution and documentation

Instructor Profile:

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. He 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, 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. He writes a recurring column for the Journal of Validation Technology. Mr. Lincoln is a graduate of UCLA.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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