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How to Prepare for and Conduct a Regulatory Audit
- 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
Overview of the webinar
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.
Who should attend?
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.
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.
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.