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Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
This Webinar is over
Date | Dec 7, 2018 |
Time | 04:00 PM EDT |
Cost | $230.00 |
Online
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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:
Areas Covered in the Session :
Who Should Attend:
- 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.
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
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