Preparing for a US FDA CGMP Compliance Audit Under 21 CFR 210, 211 and 820

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. 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. What can be expected in the weeks before the site visit, during the inspection, and post-inspection actions. Proper responses, timelines, and expected documentation.

This webinar will evaluate the chief areas of an FDA CGMP compliance inspection / audit to see actual and anticipated changes in emphasis. This information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s preparation for a successful US FDA CGMP compliance inspection.

QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive, and aggressive / robust remediation program for any regulated industry. Other details include:

• Software, data integrity, and cybersecurity issues.
• The “must dos” when a notice is received of a pending FDA inspection.
• Personnel and staff training for the visit. Physical facility considerations.
• A “typical” inspection scenario.

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; what is the FDA “thinking”
• Tougher FDA Expectations / Requirements
• Avoid complacency from past "good" FDA / Notified Body / ISO audits
• Key pharmaceutical CGMP concerns
• Key medical device CGMP concerns
• Other / associated inspection issues
• What to expect before, during and after a US FDA CGMP inspection
• Important and required post-inspection actions

Who Will Benefit:

• Senior and middle management.
• QA personnel
• RA personnel
• R&D personnel
• Engineering personnel
• Staff and Line personnel
• Sales and Marketing
• Operations / Production personnel

From the following industries:

• Medical Devices, Pharmaceuticals, Dietary Supplements, Biologics, Human Tissue, Combination Products

Free Materials:

• Suggested formats / content will be shown in the PPT slides

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. 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 in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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