Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
December 7, 2018 - Online Event ON CA
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.