SDRAN: The Rapidly Evolving Regulatory Landscape for the Biocompatibility Assessment of Medical Devices: What Regulatory Affairs Professionals Need to Know?

The Rapidly Evolving Regulatory Landscape for the Biocompatibility Assessment of Medical Devices: What Regulatory Affairs Professionals Need to Know? Webinar Wednesday, August 19, 2020 Event Agenda: Date: Wednesday, 19 August 2020 Time*: 6:00 – 6:05 PM  Welcome and Announcements (ONLINE) 6:05 – 7:05 PM   Program...

Challenges to be Encountered while conducting FDA Remote Inspections in the Post COVID Era

Online

With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.

Get Tickets $10 – $25

Audits, Inspections, & Warning Letters – Best Practices

Online

With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.

Get Tickets $20 – $55

Secret Ways to Break into Regulatory Affairs

Online

Secret Ways to Break into Regulatory Affairs Webinar 1.5 Hours Towards Your RAC Recertification September 17th, 2020 6:00pm - 7:30pm   Location: Webinar Program Manager: Rowena Soriano Speakers: Susan Bain and Eri Hirumi Cost: Free to all but need to register.   Come and join us...