This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.
A review of recent US FDA Inspectional Observations / FDA Form 483 Observations, as well as FDA statements and actions, indicate the major areas of regulatory concern. The past is no indicator of present or future concerns. The Agency uses publicized high-profile cases to drive compliance in the regulated industries. Certain CGMP areas, e.g., CAPA, are receiving increased scrutiny. "Risk-based" (patient risk) is another. Failure to correct problems leads to Warning Letters or more severe regulatory actions. Requirement for "better science" must be evident in compliance. "Business as usual" is never acceptable, but do some of a company’s documents reflect that outdated thinking. Also changes from the EU, MDD to MDR, ISO 13485:2016 ... confusion over what is "Risk". Don't be caught off guard by these major shifts in emphasis. Refine internal audits and get your company prepared to address the FDA's most recent requirements both in the US and outside.
This tougher emphasis also affects clinical trial expectations, product submissions and company response requirements. This change has a major impact on individual compliance objectives, efforts and measurements of success. The definition of "Risk" in systems and documentation can make the difference in a "Pass" or "Fail" regulatory inspection.Areas Covered in the Webinar:
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 26 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters (RAPS) in peer reviewed journals, conducted workshops and webinars worldwide. John is a graduate of UCLA.
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. FDATrainingAlert 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.
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