Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Instructor: John E Lincoln
Product ID: 701432
Training Level: Basic to Intermediate
  • Duration: 60 Min
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2020

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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”

Frequently Asked Questions:

  1. What does the FDA look for in terms of "rework" and "reprocess". When does these terms apply; especially for labeling and packaging?
  2. What are the common FDA findings for Device History Records?
  3. What is the common inspection plan and recommended frequency for a virtual company?
  4. What is the expectation for virtual companies on how they should manage vendor quality systems?
  5. For audits focused on Material Review Board (MRB) due to non-conforming material, what does the FDA look for during the audit?
  6. For companies who have combination products filed under an NDA, are they audited against 210/211, 820, or both?
  7. Can you elaborate on P&PC key issues for verified and validated?
  8. Do "rework" and "reprocessing" term apply to visual inspection and re-packaging of drug product or finished goods?

Who Will Benefit:

  • Senior and middle management.
  • Quality Assurance
  • Regulatory Affairs
  • R&D
  • Engineering
  • Staff and Line personnel
  • Sales and Marketing
  • Operations / Production
Instructor Profile:
John E Lincoln

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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