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Good Auditing Practices, Making the Most of Your Internal Review

Virtual Short Course

Presented by Tamika Cathey, EAS Independent Consultant

July 18-19, 2022
11am – 3:00pm 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 seminar Good Auditing Practices. Taught by EAS independent consultant, Tamika Cathey, this eight-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

$499.00$549.00

Clear

All seminar registrations are per person.

Discounts

Federal and State Employees may use GOV50 at checkout for a 50% discount.

Two or more employees from the same firm may use GROUP10 for a 10% discount.

* Only one discount code per transaction

Cancellations

EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.

Cancellations will be refunded minus a $95 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.

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About the Presenter

Tamika Cathey

Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and works to design improvement programs based on findings. Tamika has a B.S. in Biology from Greensboro College in North Carolina. Prior to consulting she held positions such as Associate Director, Regulatory Affairs for Charles River Laboratories, and Consumer Safety Officer at FDA’s Atlanta District.

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