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Are you ready for your next regulatory inspection? On site or virtual in 2021 - Live Webinar


Location: California, USA
From: 2021/03/25 10:30
To: 2021/03/25 12:00
Posted by: WCS Compliance

About this Event

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Training Overview

Fortunately, Alan Golden Principal at Design Quality Consultants, LLC with over 30 years’ experience working in the medical device industry will go through discussion and examples, participants will gain an understanding of how to prepare for and stage and audit, strategies to conduct 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.

Webinar Takeaway

The following topics will help guide the discussion:

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 training course is a practical, hands-on course designed to provide all FDA-regulated industry professionals with the information and tools they require to prepare for and manage an FDA inspection.

This course is ideal for:

  • Managers/Directors of Regulatory Affairs and Quality Assurance
  • Auditing
  • Documentation Management
  • Plant and Executive Management
Alan Golden ( 30+ year exp.)

Principal at Design Quality Consultants

Wilmette, Illinois

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.




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