Conducting Successful FDA Meetings

Instructor: Larry Stevens
Product ID: 706198
Training Level: Intermediate to Advanced
  • 15
  • November 2019
    Friday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. Knowing what makes FDA employees the way they are, will help immensely in understanding how to deal with FDA.

Live Online Training
November 15, Friday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$229.00
One Dial-in One Attendee
$599.00
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recorded version

$299.00
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Training CD / USB Drive

$399.00
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CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

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Live + Recorded Version

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Live + Training CD/USB

$499.00

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Read Frequently Asked Questions

Why Should You Attend:

Knowing the background and working conditions of FDA employees, you will better be prepared to deal with FDA. You will be able to assess the FDA person, and then use the information from this webinar, to improve your understanding of FDA, improve your communications with FDA and the overall FDA experience.

For most firms the most common GES dealing is with an FDA Investigator during an FDA Inspection. But firms that get into FDA trouble, it also means dealing with FDA Compliance Officers. In addition, for firms that develop or manufacture products requiring FDA approval, it means interacting with FDA Scientists, and Engineers.

During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry. We will also explore FDA managers and how they approach their job, which has a direct impact on how you try to resolve FDA problems.

If you assume the way an FDA employee’s mind works, by using the model that you have seen in your private industry experience, you may find yourself very confused by actions and words of an FDA employee.

Areas Covered in the Webinar:

  • Become familiar the types of jobs within FDA and the qualifications needed to serve.
  • Know what motivates an FDA employee.
  • Know how FDA employees are trained.
  • Become familiar with the methods of dealing with FDA personnel to achieve a desired outcome.
  • Know how to meet with FDA and what to not say or do.
  • Know how to negotiate with an FDA manager to resolve issues.
  • Know how to train your own employees in methods of dealing with FDA.

Who Will Benefit:

  • Employees from RA, QA and Clinical departments in the FDA regulated industry. Persons from R&D who might attend FDA meetings or talks with FDA during inspections. Industry consultants who work with FDA regulated firms. FDA employees who might want to learn how they are viewed from the industry perspective.
Instructor Profile:
Larry Stevens

Larry Stevens
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert

J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant he has presented over 20 webinars on FDA requirements.

Mr. Stevens has met numerous times with FDA as a member of industry, and with industry numerous times as an FDA Official. He is keenly aware of what pitfalls must be avoided, and what FDA expects from the firm with whom they are meeting. Now as a consultant, Mr. Stevens assists firms in meeting FDA requirements and conducting successful FDA meetings.

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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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