A FDA Audit - What You Need to Know

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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