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:
Sales & Marketing Management
Scientific Staff (Advisors)
Clinical Staff (Advisors)
Research & Development Management
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
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