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Meet the Tougher U.S. FDA CGMPs - Webinar

  • ID: 4899702
  • Webinar
  • November 2018
  • Region: United States
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.

And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace – all preventable by the effective internal CGMP compliance audit / inspection.

During this session, 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 information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s internal audit program. QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive and aggressive / robust internal audit program for any regulated industry. Software, data integrity, and cybersecurity issues. A suggested annual time line will be presented. The “must dos” when a notice is received of a pending FDA inspection.

This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).

Areas Covered in the Webinar:

Basic U.S. FDA's expectations – the CGMPs
The "target" - Tougher FDA Expectations / Requirements
Avoid complacency from past "good" FDA / Notified Body / ISO audits
Key medical device and pharmaceutical CGMP concerns
A risk-based phased approach
FDA “model” CGMP inspections
Prove / maintain 'in control'
Fight “entropy”
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John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time 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 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln 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. Mr. Lincoln is a graduate of UCLA.
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