Sale Date Ended
Sale Date Ended
Course "Medical Device Registration and Approval Process for the Pacic Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness
Overview:
Why should you attend:
Areas Covered in the Session:
Who will benefit:
This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Asia Pacific and with the corresponding regulatory authorities. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the medical device registration process, including:
Medical Device Registration and Approval Process
Exercise and Recap of Day 1
Medical Device Registration and Approval Process
Exercise and Recap of Day 2
Debrief/Adjourn