Complaint Handling for Medical Device Manufacturers
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As an experienced FDA medical device investigator, approximately 90% of all FDA 483 I've issued contained inspectional observations that included firm's inability to establish and implement Complaint Handling procedures in compliance with 21 CFR 820, or failed to follow their own established procedures. Either way can get a firm into sufficient Warning Letter territory.
There are requirements for every medical device firm to comply in both FDA and ISO 13485 for the properly collection, investigation, root cause determination and corrective actions required when a complaint is received requiring properly handled of each complaint within your organizations.
What are the pitfalls in Complaint Handling? We will discuss many of these during the webinar and provide sufficient time for specific questions. Please bring some of your most challenging complaints for discussion. This will benefit all attendees.
Why should you Attend: Many medical device firms struggle deciding when a complaint is a complaint and when to investigate.
There are specific definitions in 21 CFR 820.198 which provide information as to the requirements for Complaint Handling; however, some firms have difficulty implementing these regulations.
This webinar will assist the viewer with how to determine if a customer call should be handled as a complaint, service call or just an inquiry. I will provide information expected to be performed by you on all service calls logged by your firm.
Sufficient time will be provided for Q&A.
Areas Covered in the Session:
Who Will Benefit:
- What is a Complaint
- What is an Inquiry
- Who in your firm should take complaints
- How to Handle Service Reports
- When to report to FDA
- How to report to FDA
- All Medical Device manufacturers
- Medical Device Investigator
- Risk Management Specialists
- QA Managers
- Regulatory/Legislative Affairs Professionals
- R&D and engineering staff
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 as a follow-up to 20 plus years experience with the FDA and USDA.
Mr. Lagrotte's previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.
His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods 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 thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.
Presently, 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.
At FDA and USDA he received numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.