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Nice response to my questions and good suggestions for moving forward.
Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,
I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.
Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

 Speaker Profile


John E Lincoln
Consultant, Medical device and Regulatory affairs,

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.
 Upcoming Webinars
Change Control - Key to Successful cGMP Compliance
There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.
Live  Wednesday, June 12, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Setting Up and Running a Tougher Supplier Audit Program
The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual".
Live  Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Compiling the Design History File, and Technical File / Design Dossier
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
Live  Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Risk-based Software Verification and Validation
The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Live  Wednesday, July 24, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
...more
 Recorded Webinars
Risk-Based CAPA Systems
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems.
Recorded ,
$295.00
Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded ,
$295.00
Best Selling Medical Device Webinars by John E. Lincoln
CompliancePanel brings you a special offer on Medical Device Recorded Webinars.
Recorded asd,
$795.00
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded ,
$295.00
...more


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