How to Prepare for and Conduct a Regulatory Audit
Instructor: Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 should you 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
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.