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

Description :

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 Will Benefit:

Regulatory Compliance Professionals

Quality Assurance Professionals

Quality Control Professionals

Regulatory Affairs Professionals

Complaint Handling Professionals

Quality Engineers

Service Technicians and Engineers

Manufacturing and Design Engineers

Process Development Personnel

Customer Service Personnel

Sales Representatives