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Medical Device Single Audit Program Preparation


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Compliance4all
Healthcare
Contact Provider
N/A
TBC
Conference (Online)
-
-
£150.00
Corporate Management, Quality Management
Online / Distance Learning Course

Overview:
The International Medical Device Regulators Forum (IMDRF) recognizes
that a global approach to auditing and monitoring the manufacturing of
medical devices could improve their safety and oversight on an
international scale.

Why should you Attend:
Today with a single audit, it is possible for a medical device manufacturer
to satisfy the quality management system requirements of Australia, Brazil,
Canada, Japan and the USA! This is the benefit of the Medical Device
Single Audit Program, or MDSAP. However, there are some vital
considerations before embarking upon this approach to satisfying the
regulators of five major markets.

Areas Covered in the Session:
Origin of MDSAP
Applicability of MDSAP
Advantages of MDSAP
Disadvantages of MDSAP

Who Will Benefit:
Corporate Management (Presidents, CEOs, COOs)
Quality Management (Vice Presidents, Directors, Managers)
Regulatory Management (Vice Presidents, Directors, Managers)
Sales & Marketing Management (Vice Presidents, Directors, Managers)

Speaker Profile:
Shep Bentley is the President and Principal Consultant for Bentley
Biomedical Consulting, LLC, where he is responsible for regulatory
strategies leading to FDA approvals and clearances for digital medical
device companies. Shep began his career in 1984 at the Hospital
Corporation of America as a research technician, and worked at McGaw
Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA
America where he managed production of various digital devices.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]




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