Getting Ready for Tougher FDA GMP Inspections – Feb. 15, 2012, 2-3:30 PM EST
December 19th, 2010 // 4:08 pm @ jmpickett
Recent FDA audits have shown us that 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. Recent events in regulated industries indicate a public’s growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA.
How this is affecting the Agency’s approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. They also use GMP compliance audits to drive companies to do much of their work for them. How they drive companies to do much of their work for them. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate.
This new Webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA’s CGMP audit “paradigm”. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
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Who Should Attend:
This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA’s CGMP audit “paradigm”. Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include:
– Senior management
– Regulatory Affairs
– Quality Assurance
– Production
– Engineering
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, r oot cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.
About the Speaker:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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 so+E6ftware 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 published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
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