Live Webinar Development and Audit of Complaint Handling and MDR Processes

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"

Application of risk management to complaint handling program

Description

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.

A firm must implement an effective system to capture, document, correct and trend complaints, and equally important, to evaluate and identify customer feedback as to whether it qualifies as an MDR event. This webinar will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action. Also addressed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. The application of risk management to a complaint handling system will be included

Areas Covered

•    FDA requirements for complaint handling
•    Establishment of complaint handling program
•    What constitutes a complaint
•    What constitutes an MDR event
•    Evaluation of feedback as MDR: gray areas
•    The roles of investigation and corrective action in complaint handling
•    Complaint trending and reporting
•    Application of risk management to complaint handling program

Who will Benefit

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

•    Executive/senior management
•    Regulatory management
•    QA management
•    Any personnel who may have direct interaction with FDA officials
•    Consultants
•    Quality system auditors

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

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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