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Event Manager
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description


This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs.

It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use of existing FDA tools by a company will be discussed. What are the expected industry trends for the future as indicated by recent FDA and other guidance documents, for which companies should now prepare?

Why Should You Attend: 

The FDA expects companies to perform meaningful, results driven manufacturing process validation, now including considering life cycle issues. While the company is held fully responsible for deciding how it will conduct process validation, alternate approaches require longer and more stringent documented rationale. Growing high-profile field problems indicate that validation and change control and its effect on regulatory review activities are not yet fully utilizing the power of current FDA guidance and associated tools, which must be a part of such an analysis. A growing push by the Agency to toughen the regulatory process in the U.S. is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered In the Session:

  • Key process validation requirements
  • Current expectations
  • Recent process validation guidance documents
  • Lifecycle considerations
  • Expectations for the future as indicated by ICH Q7 and Q8
  • The "Controlled Process"

Who will benefit:

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel tasked with process verification and validation

Speaker Profile:
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
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Not sure if you want to exhibit at or attend the Webinar on Process Verification and Validation? See the panels below to get the information you need to make an informed decision.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Event Details

Conference/Event Dates: 06/29/2016 - 06/29/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Manufacturing - General
Other Industries: Manufacturing, Manufacturing - General
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: Senior Management
Regulatory Affairs
Quality Assurance
R&D and Engineering
All personnel tasked with process verification and validation
Number of Exhibitors:1

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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