Live Webinar Medical Device Complaints and Corrective and Preventative Action (CAPA)

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

"Hear By Edwin Waldbusser is a consultant retired from industry after 30 years in management of development of medical devices (5 patents). "

This CAPA webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device, and Identifying the root cause of corrective and preventive actions and complaints can be challenging.

Description

This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be discussed. Post distribution product monitoring including customer surveys will be explained. Integration of manufacturing non conformaties with the CAPA program will be discussed.

Why should you Attend:
 
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is striking a balance between too many CAPA’s (strangles the system) and too few (problem areas escape fixing)

Areas Covered

•    CAPA phases to be discussed:
•    Sources of information (complaints)
•    Information gathering & proactive information gathering
•    Information evaluation (is it a Complaint, is it a CAPA, should it be investigated)
•    Risk analysis applied to CAPA
•    Root cause determination
•    CAPA Investigation Report & CAPA action Plan
•    Verification/ Validation of CAPA action
•    Post closing effectiveness check
•    CAPA program metrics
•    Complaint Evaluation form
•    Corrective Action Plan form

Who will Benefit

•     Medical Device Engineering
•     Quality Assurance
•     Regulatory
•     Management

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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