How to Prepare for and Conduct a Regulatory Audit
Instructor:
Alan M Golden
Product ID: 706849
Training Level: Intermediate
- Duration: 60 Min
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.
Areas Covered in the Webinar:
- 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:
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.
Instructor Profile:
Alan M Golden
Principal, Design Quality Consultants
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
