FDA/EU MDSAP Inspections - Getting Prepared


Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; GCP, Supplier Qualification, Audit, CAPA, and Master Validation Programs. MS. Dorat has worked with Implantables, Wearables, Vaccines, IVDs, Medical Devices with software as well as Software as a Medical Device and mobile application devices. She has also published articles on vari........

Overview

Inspections are critical to the success of the business on several levels. Therefore, being appropriately prepared and management of the inspection process is a critical activity. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

Why should you attend this webinar?

This webinar has been specifically designed to help attendees prepare for FDA /EU & MDSAP inspections. It will provide a background and understanding of the role played by the regulatory inspectors and the administrative and enforcement powers. Attendees will be taken through the key stages of the inspection processes and understand the various types of inspections that can be carried out.

Areas Covered in the Session:

By the end of this course, participants will have a understanding of:
  1.  Differences between FDA and EU Inspections including 
  2.  MDSAP Inspections - What to Expect
  1.  What will they look at?
  1.  Setting up a Triage to ensure that required documents are available
  2.  How to plan for an inspection using checklists
  3.  Preparing employees before the inspect
  4.  Tips on proper responses to inspection interviews questions
  5.  How to interact with the inspectors-DOs and DON'Ts
  • How to reply to inspection reports, 483's and EU inspection finding
  • Post inspection actions - implementing appropriate CAPAs in response to audit findings

Who can Benefit:



Webinar Id: LSHCMDF001

Training Options:

Duration: 75 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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