Complaint Handling Requirements (US)

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. 

The FDA consistently has focused on complaints as part of post market surveillance. Numerous citations are related to deficiencies and lack of implementation or effective implementation of complaint handling activities, documentation, and the disconnect between complaints with CAPA/change control/adverse event reporting/recalls. Regulated companies don't always establish and implement a unified approach to these regulated systems.

This 90-minute accredited course is intended to help you better understand and get familiar with the 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

In addition, the course will incorporate the complaint handling life-cycle process and an example of activities involved in this life cycle. Furthermore, this training will discuss complaint handling implementation challenges, in addition to pitfall challenges. At the end of this course, 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.

THIS TRAINING IS PART OF OUR FDA READINESS PROFESSIONAL CERTIFICATION

• To enroll into the complete FDA Readiness Professional Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications

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