Regulatory Audit Preparedness

Regulatory Audit training provides participants with valuable insights into effective preparation, execution, and response strategies. This comprehensive session covers the essential aspects of conducting successful audits and addresses the unique challenges posed by virtual audits in light of post-pandemic.

Regulatory Audit is an integral part of the medical device and pharmaceutical industry, where audit outcomes can significantly impact product approval and manufacturing operations. To ensure a favorable outcome, understanding the audit process and being equipped with the right resources, staff, and facilities are paramount.

The key to a successful regulatory audit lies in meticulous preparation and conducting the audit with utmost care. By focusing on strategic planning, appropriate staffing, and advanced preparations, you can greatly influence the outcome of the audit. This webinar delves into the crucial aspects of strategy, staffing, and proactive measures necessary to host a regulatory audit that yields positive results.

Areas Covered in the Session:

• 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 Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Scientists
• Everyone that supports during an audit

Course Director: ALAN M. GOLDEN

Alan has over 30 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 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.