Get 50% off with the coupon code COUPON50How to Prepare For and Conduct a Regulatory Audit
- Tuesday
- July
- 08
- 2025
Alan M Golden Overview:
This Session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, 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.
Why you should Attend:
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.
Areas Covered in the Session:
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.
- 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:
The following professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:
- Quality Systems
- Quality Assurance
- Quality Control
- Change Control
- Engineering/R&D
- Regulatory Affairs
- Manufacturing
Speaker Profile
Alan M Golden has over 35 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 16 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 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.