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FMMC Executive Briefing: FDA Inspection Trends
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FMMC Executive Briefing: FDA Inspection Trends

Bi-monthly FMMC networking and educational event on FDA medical device inspection trends. What are some of the FDA's recent medical device inspection priorities? And what changes are occurring in their audit approaches and techniques? Join us for this special event to learn what to prepare for and how to succeed during an FDA audit. Breakfast served @ 8am

9/24/2015
When: 09/24/2015
8:00AM
Where: Hilton Carillon Park
950 Lake Carillon Drive
St. Petersburg, Florida  33716
United States
Contact: FMMC
(850) 270-3158


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Guest Speaker:  Leo J. Lagrotte

The FMMC's fall networking and education programming kicks off on September 24th with an Executive Briefing featuring former Medical Device FDA inspector, Leo J. Lagrotte, a 20+ year veteran with the FDA and USDA.

 

What are some of the FDA's recent medical device inspection priorities? And what changes are occurring in their audit approaches and techniques?  Join us for this special event to learn what to prepare for and how to succeed during an FDA audit.

 

About our Speaker:  Mr. Lagrotte's experience with the FDA commenced as an investigator in the Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments, then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over 35 foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with the FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.

Leo Lagrotte currently serves as a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers. Mr. Lagrotte's focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients.

 

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