Management Responsibilities for QSR Initiative

Speaker

Instructor: Daniel O Leary
Product ID: 705798

Location
  • Duration: 90 Min
The management responsibility section of the QMS is one of the most important parts because it sets the tone for other sections. If you are involved in any aspect of management responsibility, then you need to understand how to set up the system as well as what can go wrong. This presentation provides you with an explanation of the issues, implementation tools, and illustrations of problems that could arise.
RECORDED TRAINING
Last Recorded Date: Sep-2018

 

$269.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

Why Should You Attend:

Management responsibility is the name of a QSR section that describes how top management sets up the quality system. There are significant elements of this system that are essential to a smooth running QMS. Understanding them is vital. In addition, ISO 13485:2016 mirrors the QSR requirements, but also diverges. For example, QSR requires a quality policy and quality objectives, while ISO 13485:2016 adds some specific areas to include.

Other QSR sections support management responsibility. For example, the quality audit program provides information to management on the QMS effectiveness. The Quality System Record contains necessary QMS information.

This presentation explains the required elements of management responsibility and the supporting sections. The approach looks at QSR as seen through the regulations, the preamble, QSIT, and Warning Letters. In addition, the presentation looks at the ISO 13485:2016 requirements, the handbook, and the MDSAP audit criteria. The result is a unified explanation of how to meet the combined requirements of both systems.

Bonus Materials:

Participants receive checklists to help ensure effective implementation of the management responsibility.

Areas Covered in the Webinar:

  • Understand the required elements to implement management responsibility
  • Understand the differences between QSR and ISO 13485:2016
  • Develop unified documents and records for a combined system
  • Understand the role of the Quality System Record
  • Learn how FDA Investigators use QSIT to check your implementation
  • Learn how MDSAP Auditors use the audit model to check your implementation
  • Review Warning Letters to learn implementation problems

Who Will Benefit:

All people involved in the management responsibility system should attend. In particular:

  • Top Management
  • Management Representative
  • Management Review Participants
  • Quality Managers
  • Audit Managers
  • Managers responsible for the Quality Plan
Instructor Profile:
Daniel O Leary

Daniel O Leary
President, Ombu Enterprises, LLC

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method