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Introduction

Areas Covered in the Session:
Change Control - what it is; what it is not
Areas impacted by Change Control
Regulatory / FDA 483 "Hot Buttons"
Design Control and Filing a New 510(k)
Document Control
Identifying Changes
Preventing Negative Changes and Entropy
Give the FDA It's Desired 'State of Control'
Business Needs and Obtaining Stakeholder 'Buy-In'

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Speakers

• 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., United States

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Venue

Online Webinar

Online Webinar, 161 Mission Falls Lane, Suite 216, Fremont, 94539, United States

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Committee

• Compliance4all Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits., United States

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Contact information

Adam Fleming
Compliance4all
161 Mission Falls Lane
Suite 216 Fremont USA 94539
8004479407
Contact us by email

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