- Date: September 12, 2019
- NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays.
- Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
- Time: 12:00 PM PST | 03:00 PM EST
- Duration: 60 Minutes
About the Seminar
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.
About the Areas to Be Discussed
- 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
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
About the Seminar 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.
LIVE (one attendee): $199
LIVE (≤ 4 attendees): $699
LIVE (≥ 5 attendees): $899
LIVE & Recorded: $299