Preparation for FDA Inspections

Speaker

Instructor: Paul Larocque
Product ID: 706620
Training Level: Basic to Intermediate

Location
  • Duration: 90 Min
This course will describe the preparations needed for and the process during and after an FDA inspection. The legal authority will be discussed along with the documents and facilities FDA is entitled to see.
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Why Should You Attend:

This webinar will help pharmaceutical, biological, and medical device personnel understand the objectives FDA has when doing inspections, the process FDA uses, and how the company can manage those FDA expectations. The roles of the various employees involved will be defined, the logistics, document management, plus front-room and backroom management.

  • You will learn what their role is during the inspection.
  • Subject-matter experts will learn their role.
  • Scribes, Runners, and Backroom personnel will each learn their roles.
  • Learn what FDA is entitled to see; and what they are not.
  • The role of daily warp ups.
  • The issuance of an FDA Form 483.
  • Responding to a 483.

Areas Covered in the Webinar:

  • Before FDA arrives.
  • When FDA arrives at the door.
  • The inspection room. – the “front room.”
  • The “Backroom.”
  • Your role.
  • The Tour.

Who Will Benefit:

Drug, biologic, and medical device personnel working in production, R&D, regulatory affairs, QA, and QC.

Instructor Profile:
Paul Larocque

Paul Larocque
President, Acerna Inc

Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.

Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.

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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.If you have any concern about the content of the webinar and not satisfied 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).

 

 

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