Quality Agreements Made Easy (Advanced 2018)

Overview:
The requirements for the assurance of quality within networks and

circles of entities whose responsibilities are increasing specialized

present an especially vexing challenge to the managements of each of

these organizations. The specification developer must be aware of the

capabilities of the contract manufacturer and the contract

manufacturer must be aware of the limitations of the specification

developer, for example.

Why should you Attend:
To the extent that anyone responsible within a specification

developer, contract design organization, purchasing organization,

supplier of critical or crucial materials or services, or contract

manufacturing and/or testing organization is concerned about

conformity to the ISO 13485:2016 or compliance to the FDA

regulations and imminent European Medical Device Regulation, this

webinar is for you.

Areas Covered in the Session:
What are the consequences of mistakes in quality agreements?
How hard does drafting a meaningful quality agreement have to be?
What do regulators look for in these quality agreements?
How often should a quality agreement be reviewed? Revised?
What if I cannot achieve agreement with the other party?
Tips for making a quality agreement acceptable to all

Who Will Benefit:
Regulatory Management
Regulatory Consultants
Quality Management
Sales & Marketing Management
Scientific Staff (Advisors)
Clinical Staff (Advisors)
Research & Development Management

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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WHEN AND WHERE

14 September 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health