Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Danielle DeLucy

Starting at

$449


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This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. 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.

Why Should You Attend:

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

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.

Learning Objectives:

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 webinar will provide attendees with:

  • Detailed information to help you gain a better understanding of the requirements of a complaint handling system and the interrelationship of other regulated activities have with the referred system.
  • Understanding of a complaint handling life-cycle process with an example of actual activities during this cycle.

Areas Covered in the Webinar:

  • Complaint definition
  • Medical device and drug complaint handling requirements (US)
  • Complaint sources
  • 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
  • What may trigger a recall during the complaint investigation
  • Recall classifications
  • Complaint handling life-cycle process (including an example that embraces activities related to bullet four, above)
  • Challenges
  • Conclusion
  • References

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
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.


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