Why Should You Attend:
The session will include requirements for complaint files and key requirements of:
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.
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:
Areas Covered in the Webinar:
Who Will Benefit:
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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