The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

$999.00
Introducing
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Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Jun-2021

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Email: customercare@fdatrainingalert.com

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Why Should You Attend:

Without adequate preparation and cross-functional communication, it is difficult to manage a good FDA inspection. Your goal is to illustrate your firm is in substantial compliance with all regulations, but also to respond to the inspector’s questions or concerns in a timely manner. This webinar will identify systems and processes, and recommended tactics, to make the inspection as painless as possible.

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the seminar:
  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
  • SOP for inspections
  • Behavior during inspection: What to say and do, and what NOT to say and do
  • Inspection process
  • How and when to craft a written response
Who will benefit:

This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs;
    • Quality Management System;
    • Quality Assurance;
    • Product Development;
    • Engineering;
    • Manufacturing;
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training personnel
  • Document Control Personnel
Instructor Profile:
Jeff Kasoff Jeff Kasoff

Director of Quality, Medivators

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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