Prepare for Your cGMP Inspection

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This webinar will focus on the U.S. FDA’s FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives.

Issues discussed should be a key consideration of a company’s Internal Audit Program, and annual Quality Management Review. It should be noted that many of the FDA’s initiatives are also part of ISO 13485 and ISO 9001 (international / global) compliance requirements.

The U.S. FDA expects regulated companies to be ready at any time for a cGMP compliance audit. Even with a pre-announced inspection date, there’s little a company can do if they weren’t already prepared for an audit by being always in compliance.

How can this be assured?
What are the must-have elements of the cGMPs & Why?
What should be the focus of a company’s quality management system and its ability to meet the current GMP’s?

The FDA has added a “Strategic Priorities” initiative that can assist companies to proactively address areas of GMP concern. There is a major shift (on-going) in the emphasis of the U.S. FDA cGMP compliance audits, and expectations for a fully compliant cGMP / QMS system.

In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company’s QA/RA and its senior management. There is “no business as usual”. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Ongoing negative publicity on pharmaceuticals, devices, as well as events in unrelated industries show many senior executives “just don’t get it”, resulting in public pressure on the Agency to “get tough on compliance / enforcement”. This webinar will trigger such a response by an examination / review of FDA’s “must-have’s” for corporate cGMP compliance.

Areas to be Covered:

Industry trends
Recent FDA actions / FY 2013 483 observations
The FDA’s recently instituted annual “Strategic Priorities” initiative
Emphasis on 2014, and future issues
A review focusing on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Management Review of their existing quality management system / CGMP compliance
An additional review of recent information from the Agency
Other goals of the Agency that have already been translated into action
Further direction in areas of concern and what to expect in the future
Process validation
Wireless device guidance
The new UDI initiative and counterfitting concerns
The global supply chain, lifecycle, combo products, “better” science, and expanding “risk based” applications

Who will Benefit:

This webinar will provide valuable information to all regulated in reviewing and modifying their regulatory complaince stance. Its principles apply to Personnel / Companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Senior management
Middle management
Research & Development
cGMP Instructors
Verification and/or Validation Planning Teams
Execution and Documentation Teams

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

This product is currently out of stock and unavailable.

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  • Presentation Handout in .pdf format
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