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UPCOMING Webinars
Use of Excel Spreadsheets in FDA-Regulated Environments under 21 CFR Part 11
Why you should attend: This seminar will provide great opportunities to improve our awareness and better implement part 11 and computer system validation re..

Live Session By Dr. David Lim On Wednesday 21st of August 2019 10:00 AM PDT | 01:00 PM EDT
FDA 510(k): Preparation, Submission, and Clearance Medical Devices
This webinar is intended to discuss regulatory requirements for FDA 510(k)s: in particular, 510K) preparation, submission and a successful clearance under the c..

Live Session By Dr. David Lim On Wednesday 21st of August 2019 11:00 AM PDT | 02:00 PM EDT
Risk Analysis and Risk Mitigation
Goals The specifications usually miss about 60% requirements. Therefore risk risks are inherent in design, manufacturing, and device use even after so much a..

Live Session By Dev Raheja On Friday 6th of September 2019 10:00 AM PDT | 01:00 PM EDT
Fundamentals of Regulatory Affairs in Human Drugs
Why you should attend:      To understand and become familiar with the Fundamentals of Regulatory Affairs in Drugs   Topic De..

Live Session By Dr. David Lim On Friday 13th of September 2019 10:00 AM PDT | 01:00 PM EDT
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also..

Live Session By Jerry Dalfors On Friday 20th of September 2019 10:00 AM PDT | 01:00 PM EDT
Best Practices for FDA Inspection Preparation and Management
This webinar is intended to help you get familiar with the best practices for FDA inspection preparation and management integrated with emotional intelligence (..

Live Session By Dr. David Lim On Friday 27th of September 2019 10:00 AM PDT | 01:00 PM EDT
Medical Device Reporting (MDR)
Description of the topic: Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or con..

Live Session By Jerry Dalfors On Friday 4th of October 2019 10:00 AM PDT | 01:00 PM EDT
Designing a Good Medical Device
Goals Designing a good medical device is an art as well as science. Engineering 101 sciences say we should always have 100% design margin. This science seems..

Live Session By Dev Raheja On Thursday 17th of October 2019 10:00 AM PDT | 01:00 PM EDT