Webinar On Establishing a Robust Complaint Management System
November 20, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
This Webinar will breakdown the complaint management process so attendees will be exposed to a clear, concise and compliant approach to complaint management in accordance with 21 CFR, Part 820.198 requirements. Remember, there are no such things as maximum compliance or minimum compliance; there is just compliance when it comes to meeting the FDA’s requirements for the complaint management system. Areas Covered in the Session : Reviewing the Requirements Associated with 21 CFR, Part 820.198 Understanding the agency’s interpretation of processing complaints in a timely and uniform manner. Information that needs to be incorporated into a complaint file. The complaint investigative process. Processing oral complaints. Use of decision trees to determine the need to report a complaint as an MDR reportable event. The documentation process for when a decision is made not to investigate a complaint. Customer response letters and follow-up. Linkage to the CAPA System Who Will Benefit: Quality Professionals Regulatory Professionals Customer Service Professionals Medical Science Professionals Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299