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

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
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

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

Vanessa Lopez

Vanessa Lopez – Sr. Principle Quality, Regulatory and Compliance Consultant, has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities.

Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance