FDA/EU MDSAP Inspections – Getting Prepared
Duration : 75 Minutes
Marie Dorat,
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; Read more
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.
Course Objectives:
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.
Course Outline:
• The Types of Inspections
o Differences between FDA and EU Inspections including
o MDSAP Inspections – What to Expect
• Who is involved?
o What will they look at?
• How to prepare for the Inspection
o Setting up a Triage to ensure that required documents are available
o How to plan for an inspection using checklists
o Preparing employees before the inspect
o Tips on proper responses to inspection interviews questions
o 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs Personnels
• Quality Assurance Personnels
• Quality Control Personnels
• Compliance Personnels
• Everyone involved with inspections
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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