Surviving an FDA Sponsors Inspection - Training for success

Duration: 60 Minutes
FDA investigators (auditors and inspectors) are thoroughly trained in interview methods that will yield clues to GCP non-compliance, the sources of the non-compliance, the documentation of the non-compliance, and the sponsor’s intent (presence of misconduct or fraud) in the conduct of the non-compliance.
non-compliance issues
Product ID: 500593

Pharma staff may not know what questions to expect and how to avoid an inappropriate or inaccurate response. Sponsors commonly incur failed inspections with significant regulatory consequences to their NDA submission due in part to inappropriate responses to FDA inspectional interview questions. Training of sponsor staff before the inspection will avoid this liability. FDA does not want to receive incomplete or inaccurate information, nor do they want to have inspectional findings that are not complete or accurate. This sponsor staff training enables more accurate inspectional outcomes, as well as reducing sponsor exposure to undue regulatory consequences.

Why Should you Attend:
This webinar will teach you how to identify the non-compliance liabilities within your program and how to anticipate and respond to direct interview questions specific to those non-compliance issues.

Objectives of the Presentation:
The FDA inspectional objectives includes
  • The Sponsor regulatory obligations
  • The FDA perspective on delegation of sponsor responsibilities to CRO
  • The inspectional interview process and its three target levels- WHO will be interviewed, and why
  • How to identify and respond to questions which you cannot accurately answer
  • Indirect questions, substitution, and silence- understanding the sponsor liability of these FDA interview tools
  • The general questions that you can expect- what not to say, how much to say, and when
  • What documents are required to support the interview responses
  • The value of Sponsor preparation for the exit interview, and
  • How sponsor staff training achieved, in an anonymized case study, a successful outcome for an FDA sponsor inspection of a clinical program supporting a filed NDA wherein the FDA was reacting to CRO reports of Sponsor GCP non- compliance.
Who can Benefit:
Pharma staff at the Director, Manager and Operational Levels for
  • Research and Clinical Development
  • Pharmacovigillance
  • Medical Affairs
  • Pharmacy Research
  • Regulatory Affairs
  • Data Management.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.

Steve has extensive field experience as a CRA and as a CQA auditor, He has expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr Manager, Global Clinical Operations. His current activities as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight.

Steve has served on an IRB and has served as PI on several phase four studies. He has published a monthly international clinical trial conduct newsletter (2000-2008) and has been a frequent presenter of webinars, and seminars over a broad range of topics for FDA News and Thompson Publishing and Bioforum. GCP, Regulatory, and CQA training of academia, government (US and Canada), and pharma staff have been a large part of his activities since 1994.

His many years of experience and expertise and his interactive presentations enable participant interaction and exchange of information/options.
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