How to Prepare for and Conduct a Regulatory Audit

Overview:

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Discussion will include prestaging documents, who should be in the audit rooms with the auditors and setup of the "back room" to keep the audit running smoothly. Strategies for dealing with auditors as well as opening and closing meetings will be explored. Also we will go into what happens if you get one or more audit observations, how to respond and options.

Why you should Attend:

The successful outcome to a regulatory audit is a critical step in getting new product to market or the ability to continue to manufacture current product lines. Being prepared for and successfully hosting the audit will go a long way to ensure a good outcome. If you are unprepared, it can send a message to the auditor (or inspector) that there is something amiss with your quality system and could result in a less than desired outcome.

Areas Covered in the Session:

• Before the Audit
• Assembly of an audit team
• • Prestaging of documents and records
  • Preparing the "back room/staging room"
• Conducting the Audit
• • Required staff
  • Opening meeting
  • Tours
  • Notes and communication
  • Dailey summary
• Response to audit findings
• • Types of audit findings
  • • FDA 483 Observations
    • FDA Warning Letter
    • Justice Department Consent Decree
  • Response team
  • How fast?
  • Next steps
• How to deal with remote audits

Who Will Benefit:

• Anyone in Quality Assurance
• Regulatory Affairs
• Technical
• R&D
• Manufacturing
• Design Transfer who had a role to Support an Audit will Benefit