This presentation is intended to help global medical device firms and stakeholders adequately implement FDA-compliant medical device complaint handling systems. Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check.
To achieve compliance and to remain compliant with the FDA-compliant complaint handling systems, it is imperative that the firms accurately interpret, understand, and implement the requirements for handling all complaints (electronic, written, or ORAL).
In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling systems in your firms.
- Applicable Laws and Regulations
- Regulatory Requirements and Compliance
- Applicable Processes and Procedures
- What to Do When a Complaint Is Received
- What/How/When to Investigate a Complaint
- Complaint Investigation: Contents of Records
- Adjudicating Complains
- Implementing Interactive Systems (Complaints, MDR, and CAPA)
- Numerous Case Studies
- Speaker’s PASS-IT suggestions and recommendations
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- Complaint Managers
- Regulatory Affairs
- Clinical Affairs
- R&D engineers and scientists, managers, directors, VPs
- Compliance and Legal Affairs
- Auditors and Consultants
- Senior Management
- Anyone Interested in Medical Device Complaint Handling Systems.