A FDA Audit - What You Need to Know

Instructor: Bernice Russell Bond
Product ID: 701042
  • Duration: 90 Min

recorded version

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: Oct-2008

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This presentation will provide you with the tools to prepare for and support the audit process executed by regulatory bodies.

For most auditees, the audit process is one of uncertainty, unpredictability, and uneasiness. The process preparation can be tiring and sometimes grueling if the auditee is unaware of the appropriate actions necessary to demonstrate that your company consistently meets or exceeds current regulatory compliance requirements. This presentation will provide you with the tools to prepare for and support the audit process executed by regulatory bodies.

Areas Covered in the seminar:

  • Purpose and Scope of FDA Audit.
  • Compliance Requirements.
  • Types of FDA Audits.
  • Communication (before / during / after).
  • Inspection Techniques.
  • Employee’s roles during the audit.
  • Common Audit Deficiencies.
  • Mock inspections.

Who will benefit:

This Webinar would benefit companies within industries that are regulated by the FDA. The employees who will benefit include:

  • Quality Assurance personnel
  • Internal Auditors
  • Compliance Officier
  • Site Manager
  • Principal Investigator
  • Research Coordinator
  • Internal/External Consultants

Instructor Profile:

Bernice Russell-Bond, As President of BRUSSELL Consulting, Inc (BCI), and Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including manufacturing, financial and pharmaceutical. She has acquired practical insights, exposure to leading compliance practices, and seasoned judgment based on her work supporting the Compliance and IT Groups of Global Companies. In addition to her experience, Bernice also has the following academic credentials: B.S. in Accounting from Hampton University and an M.B.A with an emphasis in Technology Management from the University of Phoenix.

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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.

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