Why Should You Attend:
Productive interactions with FDA personnel are key to a successful company. By unstinting the mindset of FDA employees, you greatly increase the likelihood of productive interactions that will aid you company in the key area of FDA regulation.
For most firms the most common interaction with FDA this is dealing with an FDA Investigator during an FDA Inspection. But firms that get into trouble, it also means dealing with FDA Compliance Officers.
Also, 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:
Who Will Benefit:
CEO’s, COO’s, General Managers, Vice Presidents and Directors from key company functions of RA/QA and R&D Other Regulatory Professionals, Quality Assurance Professionals, and internal quality auditors. Industry consultants who work with FDA regulated firms.Instructor Profile:
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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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
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