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FDA, EU and MDSAP Inspections – Getting Prepared

 

Inspections are critical to the success of 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.

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Why You Should Attend:

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 understands the various types of inspections that can be carried out.

Areas Covered in the Session :

  • The Types of Inspections
    • Differences between FDA and EU Inspections including 
    • MDSAP Inspections – What to Expect
  • Who is involved?
    • What will they look at?
  • How to prepare for the Inspection 
    • Setting up a Triage to ensure that required documents are available
    • How to plan for an inspection using checklists
    • Preparing employees before the inspect
    • Tips on proper responses to inspection interviews questions
    • 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 Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Compliance Departments
  • Everyone involved with inspections
recording single
for 1 attendees only
recor corp
upto 10 attendees

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