Medical Device Single Audit Program Preparation
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Training by
Compliance4All
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On-Site
/ Training
USD 150.00
Details
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]
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]
Outline
Speaker/s
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. He founded Rising Star, a contract
manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim. He was a founder of Volcano Therapeutics, Inc. in 2001, which was acquired by Philips in 2015.
Special Offer
One Dial-in One Attendee
Price: $150.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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