CGMP Inspections / Auditing -- Internal and External

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear From John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries"

Past “good” inspections are no indication of future inspection

Description

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 and EU MDR inspection / 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.

The U.S. FDA is getting tougher and has “gone global”. The new EU MDR mandates a change in the Notified-Body inspection paradigm in Europe.  These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.   Past “good” inspections are no indication of future inspection results.     Once model companies have fallen.  Enhance staff awareness and modify internal inspections to match this global regulatory shift. The FDA is increasingly willing to "pierce the corporate veil" to prosecute senior management involved in lying or fraud.   Counter the negative effects of poor CGMP compliance by being proactive, being prepared with an aggressive, current internal inspection / audit program. 

Why you should attend

•         Avoid complacency from past "good" U.S. FDA/ EU ISO audits 
•         A Risk-Based Approach – What It Is, What It Is Not 
•         Drug, device, Dietary Supplement, Combo Products  Approaches
•         The Internal Audit System and Sample Schedules
•         A Valuable Training Tool
•         'In control'  -- What, How  
•         The One Key “Must Do” Once Notified of an Impending Inspection
•         Beware Entropy
•         Maintain 'the edge'

Areas Covered

This webinar will evaluate the chief areas of FDA CGMP / N-B compliance inspections, 483s and Warning Letters, guidance documents …  to see actual and anticipated changes in emphasis, how to structure a company’s own internal inspections and those of its vendors,  based on this new regulatory climate. And address the one key thing that a company must do once notified of an impending inspection.

Who will Benefit

•         Senior management 
•         Middle management / staff
•         R&D
•         Engineering
•         Marketing
•         Purchasing
•         Consultants
•         All others tasked with product development, acquisition and production

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

 


Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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, he 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. He is a graduate of UCLA.

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