Live Webinar on
Master Verification & Validation Planning under U.S. FDA CGMP, ICH
Q-series and ISO 13485-14971 Requirements
Date & Time:
Wednesday, March 21, 2012 10:00 AM PST | 01:00 PM EST
Register Now
Duration: 90 Minutes Instructor: John E Lincoln
Location: Online Price : $245.00 (for one participant)
Instructor Profile:
Overview:
John E Lincoln
FDA Warning Letters and recent high-profile recalls indicate major Consultant, Medical device
cGMP deficiencies in many companies. and Regulatory affairs,
One major failing is lack of sufficient or targeted risk-based company- John E. Lincoln is a medical device
wide V&V planning. Starting with a Master Validation Plan, evaluating and regulatory affairs consultant. He
its elements against ISO 14971 hazard analysis / risk management, has helped companies to implement
allows development of meaningful product validations. The roles of or modify their GMP systems and
procedures, product risk
different V&V protocols. How to employ equipment / process DQs,
management, U.S. FDA responses.
IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a
In addition, he has successfully
background of limited company resources (personnel, budget, time). designed, written and run all types of
A matrix simplifies "as-product", "in-product", process, and process, equipment and software
equipment, et al, software V&VT, assuring key FDA requirements are qualifications/validations, which have
not overlooked. The QMS and 21 CFR Part 11 must be considered. passed FDA audit or submission
scrutiny, and described in peer-
reviewed technical articles, and
Why Should You Attend: workshops, world wide. John has
Verification and validation requirements have always been part of also managed pilot production,
the US FDA's GMPs. However, with increasing technology, both regulatory affairs, product
development/design control, 510(k)
industry and regulatory agencies expectations have increased.
submissions, risk management per
Recent high-profile field problems indicate that V&V activities are not
ISO 14971, and projects; with over
planned or carried out as completely as expected, and may not be 28 years of experience in the FDA-
fully utilizing the power of current risk management tools, as regulated medical products industry
identified in ISO 14971. The FDA / ICH Q-series provide valuable - working with start-ups to Fortune
insights for all regulated industries, not just Pharma. 100 companies, including Abbott
Laboratories, Hospira,
Tyco/Mallinckrodt. He is a graduate
Areas Covered in the Session: of UCLA. ...more
l Verification or Validation - Recent regulatory expectations
l The Master Validation Plan / structure Suggest a Topic More Webinars
l Product Validation – how it differs from process / equipment
V&V Your Necessity is our Priority
l Process / Equipment / Facility Validation -- FDA's new guidance
l When and How to use DQ, IQ, OQ, PQ, or their equivalents
l How to use Product Risk Management Tools (per ISO 14971
and ICH Q9)
l The 11 key documents for software validation
l Incorporating 21 CFR Part 11 requirements
l Suggested “test case” formats
Click here to register for this webinar
Who Will Benefit:
l Senior management in Drugs, Devices, Biologics, Dietary
Supplements
l QA
l RA
l R&D
l Engineering
l Production
l Operations
l Consultants; others tasked with product, process, software ...
validation responsibilities
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801
Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe