Preparing for FDA Pre-Approval Inspections

Instructor: Peter Calcott
Product ID: 700894
  • Duration: 60 Min
An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed.

Description

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.

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2008

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

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

Instructor Profile:

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.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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