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How to Prepare for and Conduct a Regulatory Audit
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
Overview of the 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.
Who should attend?
- Anyone in Quality Assurance
- Regulatory Affairs
- Technical
- R&D
- Manufacturing
- Design Transfer who had a role to Support an Audit will Benefit
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.
Faculty - Mr.Alan M Golden
Alan has over 36 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 26 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.
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 10 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.