(571) 447-5500

Presented by Robert Fish, Senior Advisor for Quality and Compliance

November 16, 18 & 19, 2020
11am – 1:30pm eastern each day

FDA regularly audits facilities for compliance with GMPs, shouldn’t you?

Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes and ensure replicable efforts that track progress.

Learn the fundamentals of developing an audit program with EAS Consulting Group’s short course Good Auditing Practices. Taught by EAS Senior Advisor for Quality and Compliance and former FDA Director in the Division of Field Investigations, Robert Fish, this five-hour seminar will detail design and implementation strategies to ensure your audit program meets the high level of detail expected by FDA field auditors.

You’ve designed a robust GMP system for your manufacturing facility. Shouldn’t your audit program have the same level of detail?

Topics Covered:

  1. GMP Overview
  2. Good Auditing Practices
  3. The Facility Tour
  4. Auditing Documents and Records
  5. Auditing Personnel, Training & Hygiene
  6. Auditing Physical Plant and Grounds
  7. Auditing Equipment, Utensils & Instrumentation
  8. Auditing Quality Control and Quality Assurance
  9. Auditing Components, Packaging and Labeling
  10. Auditing Lot Control, Tracking and Traceability
  11. Auditing Master Manufacturing and Batch Production Records
  12. Auditing Specifications, Testing and Finished Product Release
  13. Auditing Laboratory Operations
  14. Auditing Investigations, Non-Conforming Products and Corrective and Preventative Actions
  15. Auditing Holding and Distribution
  16. Auditing Product Complaints
  17. Auditing Close-Out, Report and Follow-up
  18. Discussion and Next Steps

Registration

$449.00$499.00

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Discounts

Two or more registrants from the same company – 10% (use GROUP10 discount code at checkout)
* only one discount code may be used

Cancellations

Cancellations after November 2, 2020 will be assessed a $25 processing fee.

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About the Presenter

Robert Fish

Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962 and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

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