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: support@compliance4All.com