Regulatory Inspections - How to prepare for a visit from an FDA Auditor

Denise Wrestler

Starting at

$249


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This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

Why Should You Attend:

This presentation will cover how to best prepare for these inspections to ensure the process is as quick and seamless as possible. We will cover what they are required to ask for, what they will likely ask for, and how to ensure you provide information requested in a timely manner. We will also go over some tips and tricks that will also help in ensuring a smooth audit as well as how to respond to the FDA once the audit is complete. At the end of the presentation, I will answer any questions or concerns you may have regarding the FDA auditing process.

Areas Covered in the Webinar:

  • The purpose and scope of FDA audits
  • FDA forms 482 and 483
  • What exactly a QSIT audit entails and how to pass it
  • How to Develop an audit preparedness plan that you can use to execute the audit
  • Understand what the FDA will look for at the conclusion of your audit
  • Do's and Don'ts on how to address FDA representatives
  • Do's and Don'ts for your audit team
  • Tips and tricks to ensure smooth audit experience

Who Will Benefit:

  • Regulatory Professionals
  • Quality Assurance Professional
  • Executive Management
  • Individuals involved with FDA compliance
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Denise Wrestler, QA and RA Consultant , CYA Medical Device Consulting LL

Denise Wrestler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.

Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ’s monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.


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