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Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities

5243
Duration : 60 Minutes

Charles H. Paul,

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more


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.

Course Objectives:

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.

Course Outline:

• 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

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities


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