Preparing for FDA Pre-Approval Inspections
Instructor:
Peter Calcott
Product ID: 700894
- Duration: 60 Min
You are well into your phase III trial and you believe you have a potential blockbuster on your hands. You are beginning to write your NDA/BLA and you know the PAI is a long time from now. The precise time to begin the preparation for the PAI is critical. Even if you start on time, there are many elements that must be completed before the agency arrives at your doorstep. The execution of these tasks is important so that you have available all the relevant documents so that you meet the expectations of the agency. An important aspect of the task is to objectively assess where you are deficient or weak. The gap analysis helps you identify where to focus. People are your biggest resource and potentially your biggest weakness. An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed.
Areas Covered in the seminar:
- What needs to be ready before FDA walks in?
- What are the FDA expecting?
- How to manage the FDA expectations?
- When should I begin to prepare for the inspection?
- Who should be available for the inspection?
- How do you best train people for a PAI?
- Must my CEO be ready?
- What is fair game for the inspection?
Who will benefit:
This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world. The staffs that will benefit from the webinar are:
- QA and Compliance staff
- Process development staff
- Manufacturing staff
- Validation
- Regulatory affairs staff
- Project managers
Peter Calcott, Ph.D. is the President of Calcott Consulting, a consulting firm focused on supply chain, quality, clinical development, regulatory affairs and corporate compliance. He has over 30 years experience in the industry having positions in Quality, manufacturing, process development, compliance. He has worked for large Pharma as well as small biotechnology companies. He has licensed and introduced new products to the marketplace on 6 continents..
ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria.. Credit available for Live webinar Attendees only.
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