This webinar will provide the regulatory requirements (US) for complaint handling in the Medical Device and Pharmaceutical industries. The session will include requirements for complaint files and key requirements of:
Complaint Procedures
Investigations
What to document when it is determined that an investigation is not needed
What actions are required if a complaint represents a reportable event
Record retention
The course will touch on complaint sources, and details will be furnished on the interrelationships regarding Complaint Handling/Change Control/Adverse Event Reporting/and Recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
In addition, the webinar will incorporate the Complaint Handling Life-Cycle Process and an example of activities involved in this life cycle. Furthermore, this webinar will discuss complaint handling implementation challenges, in addition to pitfall challenges. At the end of this webinar, there will be a conclusion section, where points to take into account with the integration of CAPA/Change Control/Adverse Event Reporting/Recalls/Complaint Files in the Complaint Handling Life-cycle, will be detailed.
Areas Covered in the Session :
- Complaint Definition and Sources
- Medical Device and Drug Complaint Handling Requirements (US)
- Interrelationship of Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls
- Reportable Events
- When Does a Complaint Become a Reportable Adverse Event
- What in Itself is a Reportable Event
- How Does User Error Relate to Adverse Event Reporting
- Voluntary and Mandatory Reports, and Reporting Timelines
- Complaint Handling Life-Cycle Process (including an example that embraces activities related to above five bullet points)
- What May Trigger a Recall During the Complaint Investigation
- Recall Classifications
- Challenges
- Conclusion
- References
Who Should Attend:
- Regulatory Affairs Departments
- Quality Assurance Departments
- Quality Control Departments
- Compliance Departments
- Manufacturing Departments
- Complaint Handling Departments
- Engineering Departments
- Operations Departments
- Design Engineers
- Process Development Personnel
- Service Technicians and Engineers
- Customer Service Personnel
- Sales Representatives