Live Webinar
on
Software Verification and Validation Planning to Meet FDA Requirements
Date & Time: Wednesday, October 19, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview:
John E Lincoln Consultant, Medical device and Regulatory affairs,
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 /
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 peerreviewed technical articles, and workshops, world wide. ...more
ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this are accomplished in the "real world". This webinar will address software that is: l l l l
As-Product; In-Product; In Production and Test Equipment; and The Quality System.
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Why should you attend:
Your Necessity is our Priority
Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product
processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.
Areas Covered in the Session: l l
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More Webinars
Verification or Validation Current Regulatory Expectations and Recent Audit “Hot Buttons” The Project Validation Plan Product and Process / / Facilities / Equipment Software V&V When and How to Use DQ, IQ, OQ, PQ (or their equivalents) GAMP / Other Considerations The FDA’s 11 Key V&V Documentation Elements 21 CFR Part 11, QMS, Electronic Records / E-Signatures "White Box" and "Black Box" Validations
Click here to register for this webinar Who Will Benefit: l
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Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants; others tasked with product, process, electronic records software V&V 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,
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