GlobalCompliancePanel to organize RAPS pre-approved webinar on "Change Control - Key to Successful cGMP Compliance"

Top Quote A RAPS pre-approved webinar on the topic, "Change Control - Key to Successful cGMP Compliance" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 5. This webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. End Quote
  • Washington, DC-MD-VA-WV (1888PressRelease) December 05, 2012 - Of late, if the FDA has gone down in medical device companies' perception; it is mainly due to the fact that it has lately become more stringent than ever before in its regulatory demands. Most companies at the receiving end of FDA actions don't realize that all the results of FDA actions -recalls, high profile resignations and penalties are their own making. It is noticed that the most common fault line is Change Control. Lack of proper documentation of this very important aspect of regulation is the strongest reason for which FDA penalties get invited.

    This webinar will give participants a thorough understanding of how to document a proper Change Control process. This will help them to control and review device changes, which is a major requirement in determining when to file for a fresh 510 (k). Participants will learn to eliminate cGMP "entropy", which is sometimes the unintended consequence of what a Change Control process put in place to prevent.

    These are some of the usual challenges those in the regulatory profession encounter. This webinar will help participants overcome these. It will offer them ways to come up with well documented and reviewed Change Control that will meet FDA expectations.

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

    When:December 5, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.

    John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.

    For whom:
    The webinar will benefit
    o Senior management in Drugs, Devices, Biologics, Dietary Supplements
    o QA
    o RA
    o R&D
    o Engineering
    o Production
    o Operations
    o Consultants

    Duration: 90 minutes:
    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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