Complaint handling is one of the most common FDA 483 inspection observations. Therefore, we created this procedure and webinar bundle to help your complaint handling unit complay with 21 CFR 820.198 and ISO 13485:2016, Clause 8.2.2. This webinar was originally recorded as a free live webinar on October 4, 2015.

https://medicaldeviceacademy.com/comp...

The following items are included in this webinar bundle:

SYS-018 v0.3, Customer Feedback and Complaint Handling Procedure (Procedure in Word format)
LST-011 v0.1, Complaint Register (i.e., Complaint Log in Excel format)
FRM-020 v0.3, Complaint Record (Protected Form in Word format - no password)
a native slide deck for the webinar
a link to download the recording of the webinar
a quiz and training certificate

The procedure is updated to include the requirements for the US FDA (21 CFR 820.198), ISO 13485:2016, Health Canada (SOR 98/282, Sections 57 & 58), and both of the European Regulations. Cross-references to each of these requirements was added to the procedure to demonstrate compliance and facilitate certification audits. Each reference is color coded and uses symbols that can be digitally searched (i.e., [CRTL+F]). The complaint record (i.e., FRM-020) was also completely re-written (now seven pages). The updated form now includes 100% of the requirements in the US FDA's MedWatch Form 3500A. This ensures that complaint records include all the information that is needed for regulatory reporting if you determine that reporting is required.