Post-market surveillance is a critical component to effective management of the Total Product Lifecycle of your device. The ultimate goal is to have conducted a thorough approach to design development and manufacturing such that the controls in place ensure the device will be safe and effective once on the market. Post-market surveillance is an avenue to provide further intelligence about your device and if it is meeting the expectations of your company. Even with the best design development and controls, there may arise an unintended impact to the patients and customers you serve. A proactive post-market surveillance program will detect the issues and trends quickly and allow your company to react and improve the situation.
In this first advanced webinar series, the speaker shares best practices, data, and strategies that will enable the you to enhance your current post-market surveillance systems such that your system is proactive and is collecting meaningful intelligence to protect your company and your patients and customers.
Pavan Kumar Garikapati
Regulatory Domain Head, Medical Devices
This two-part series will focus on Advanced Post-Market Surveillance topics. We highly recommend (but not require) that you view the six-part Post Market Surveillance Series prior to this two-part advanced series in order to achieve maximum understanding and value. This series builds on and utilizes information shared in the Medical Device Reporting and Design Controls Series.
Who Should Attend
All functions related to quality and regulatory affairs, with specific focus on all systems that touch post-market surveillance, such as corrective actions/preventative actions, complaints, investigations, and recalls.
Each participant will receive a Certificate of Completion after each module attended upon the return of a completed evaluation form. Each participant will receive 0.1 CEU credits per hour of training. Access to webinar/s and link to the CEU evaluation form will be provided upon purchase.
Video run-times are in parentheses.
- Advanced Post-Market Surveillance Series Module 1: Manage Post-Market Surveillance Functions Efficiently and Effectively (1:23:34)
- Advanced Post-Market Surveillance Series Module 2: Harmonizing Post-Market Surveillance Processes (1:05:21)
Registrants may purchase both modules at a 15% discount, or may purchase individual modules at $99 each using the links above.
$170 for entire series (includes a 15% discount for purchase of both modules)
Government Official: $0.00 (must have valid .gov email account)