World Conference Calendar

33818 Conferences

Quality System Regulation (QSR) Management Responsibilities

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-10-28
Last Date Last Day: 2010-10-28

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This (QSR) Quality System Regulation webinar describes management responsibility by reviewing the Quality System Regulation (QSR) and the reasoning that FDA published. It covers each of the components of management responsibility and provides a list of things you should consider in your implementation.

Why Should You Attend:

One of the most common areas for FDA Warning Letters is Management Responsibility. FDA considers this a principal subsystem and is where they start inspections. Ensuring that you understand what they expect and how to implement it is a valuable approach to preventing problems.

This webinar examines the requirements for management responsibility using information provided by the FDA. We look at the structure of the regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding. The webinar looks at these terms and explains what they mean. For example, in your company, have you identified “management with executive responsibility”?.

Related Technical Documents:

* FDA QSR as published in 21 CFR Part 820
* FDA QSR Preamble as published in 61 FR 52601-52662
* QSR Paperwork Reduction Act Supporting Statement - OMB No. 0910-0073
* Guide to Inspections of Quality Systems
* FDA Warning Letters

Who Will Benefit:

This webinar provides information for people involved in medical devices regulated by the FDA. People in the following roles can especially benefit from the knowledge in this webinar:

* Device company executives
* Device company managers
* Quality Managers
* Regulatory Affairs Managers
* Risk Managers
* Management Representatives
* Production Managers
* Design Engineering Managers
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