- Duration: 60 Minutes
- Product Code: GCS14-100R (Recorded)
About the Seminar
As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.
FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.
…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”
This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) 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 be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.
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 and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.
About the Areas to Be Discussed
- Applicable Laws and Regulations
- Requirements for Complaint Handling
- Requirements for Medical Device Reporting
- Applicable Processes and Procedures
- Key Elements in the Procedures: Complaint Handling and MDR
- What to Do When a Complaint Is Received
- What/How/When to Investigate a Complaint
- Complaints Investigation and Documentation
- Medical Device Reporting
- How to Determine Reportable Events
- Establishing Reportability Criteria
- Additional Documentation Requirements for MDR
- Mistakes and How to Avoid Mistakes and 483s
- Relationships between Complaint Handling, MDR, and CAPA
- Enforcement Case Studies
- Improving Our Awareness and Continuous Improvement
- Speaker’s PASS-IT suggestions and recommendations
About the Intended Attendee(s)
- 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
- This is excellent – Quality Director
- Your explanation was very polite, precise and helpful for me.
- I would like to recommend this webinar to our QA team – RA and Marketing Department
About the Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.
Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.
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