Effective Complaint Handling for Medical Devices

Course Title: Effective Complaint Handling for Medical Devices

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3056

INTRODUCTION
The medical device industry is highly regulated due to the product risk to health and this risk is as well an important factor in complaint handling. This training program on medical device complaint handling is based on FDA regulations and the regulatory process as well as requirements from ISO 13485:2016 and MDR with respect to Medical Device Complaint Handling, including processes related to NCR and CAPA.

COURSE OBJECTIVE
This course will provide participants with an overview about handling of Medical Device Complaints, from receiving complaints, registration, classification, investigation, initiating and following up of corrective actions until reporting and closing of a complaint.

COURSE OUTLINE

1. Requirements of Regulations and Standards (USFDA 21 CFR Part 820; ISO 13485:2016; MDR) related to Handling of Complaints
2. Sources of Complaints, NCRs and CAPAs
3. Selection criteria NCR/CAR/CAPA
4. Complaint Handling – structure, templates & process flows
5. Root Cause analysis / Problem solving tools
6. Reporting to regulatory authorities
7. Recall decision and process

TARGET AUDIENCE
Executives and managers and also quality personnel – anyone who may involve in the handling of complaints.

PRE-REQUISITE
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Basic awareness on medical devices, quality assurance and recognized standards (USFDA 21 CFR Part 820 & ISO 13485:2016) is also recommended.

DURATION
Two (2) full days

TRAINER’S PROFILE
Frank Ried is a German national living and working in Malaysia for more than 20 years. He holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality) and DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR Part 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

Frank has over 30 years of professional experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies (B. Braun and Ansell) and various departments during this time.

Frank left Ansell at the end of 2016 to concentrate on his own company, Ried Q&C Consulting Sdn. Bhd., which he founded in early 2015. Frank now provides consultation in the compliance areas of ISO 9001, ISO 13485 and QSR (FDA) for Medical Device companies in Malaysia as well as Asia Pacific, fully utilising his expertise and experience in Quality Management, Assurance and Control. He also conducts training course as well as internal audits (incl. Mock-FDA Inspections) and supplier audits.