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.

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

Course Director: MARIE DORAT

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution. Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics. She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months. She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.