Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
Instructor:
Vanessa Lopez
Product ID: 704758
- Duration: 90 Min
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
Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services
Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.
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