Why Should You Attend:
Recent US FDA inspections indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. See how the on-site CGMP compliance audit is changing and the FDA focus is shifting. Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection.
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years. This change in focus has a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to recent food, device, drug, vacine and infant formula shortage problems. This affects the Agency's approach to audits and their expectations for companies, with emphasis on the key CGMP areas under QSIT. This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan, conduct, and assess inspections of medical device manufacturers. It walks participants through a "typical" new, tougher CGMP compliance audit. It will figuratively "look over the shoulder" of an investigator as they walk though a device plant and perform an audit, based on the always changing regulatory climate.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP compliance. This information applies to personnel / companies in the Medical Device, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements fields. The employees who will benefit include:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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