ComplianceOnline

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

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

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

Instructor Profile:

Vanessa 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 and coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), and offers insight into 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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