Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements

This product is currently out of stock and unavailable.

Description :

This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.

And now, the FDA is taking an even tougher stance.

Why do companies need a Master Validation Plan?
What are the “must have” elements from the cGMPs?
How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?
How can these be integrated into the company’s quality management system?

Areas Covered in the Session :

Verification and Validation — Recent Regulatory requirements.
The Master Validation Plan(s).
Product Verfication & Validation.
Process and Equipment Verfication & Validation.
QMS V&V and 21 CFR Part 11.
When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents.
The 11 Elements of the FDA’s Software VT&V “”Model””.
Incorporate the Hazard Analysis / Risk Management tools of ISO 14971 and ICH Q9.
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). Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operators
Consultants
cGMP instructors
And all personnel involved in verification and/or validation planning, execution and documentation.

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.

This product is currently out of stock and unavailable.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance