How to Prepare for and Conduct a Regulatory Audit

In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the COVID-19 Pandemic.

Why Should You Attend:

Regulatory audits are a standard part of doing business in the medical device or pharmaceutical industry. The outcome of a regulatory audit can determine if a product is approved for sale or the plant itself can continue to manufacture.

Understanding the flow of an audit and being prepared with the appropriate materials, staffing, facilities can make all the difference between a good outcome and a poor one.

The successful outcome to a regulatory audit is highly dependent on preparation for and how the audit is conducted. Careful preparation, staffing and managing an audit can mean the difference between a good outcome or a poor one. This webinar will discuss the strategy and staffing, as well as advanced preparation needed to host a successful regulatory audit.

Areas Covered in the Webinar:

Preparing for a third-party audit or inspection

• Assembly of an audit team
• Prestaging of documents and records
• Preparing “back room”

Conducting the audit

• Required staff
• Opening meeting
• Tours
• Notes and communication

Responding to audit findings

• Response team
• How fast
• Next steps

Who Will Benefit:

This session is geared toward Quality Assurance and Regulatory Affairs Professionals, however anyone who will be supporting an audit such as R&D Scientists, Technical Support Scientists, Manufacturing and Production Personnel involved in audit support will benefit.