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RAPS Approved Webinar


Management Controls Under QSR and ISO 13485

Date & Time: Course "Management Controls Under QSR and ISO 13485" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.

Thursday, August 23, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Jeff Kasoff

Location: Online

Price : $245.00

(for one participant)

Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or prosecute in the event of major noncompliance, this session is key for those individuals who are members of top management, or those regulatory professionals who need to understand these requirements to assure top management is fulfilling its responsibilities. This session will discuss the requirements


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Instructor Profile: Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996. ...more

for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality Suggest a Topic plan, and of course all aspects of management reviews.

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Your Necessity is our Priority

Areas Covered in the Session: l l l l l l

QSR and ISO 13485 requirements for management controls Organizational structure Establishment of an internal audit program Establishment of your company's quality policy

Contents of your company's quality plan How/when to conduct management reviews

Click here to register for this webinar Who Will Benefit: l

Regulatory Management


Quality Assurance Professionals Consultants Sales/Marketing Management

l l l l

Senior and mid-level Management Quality System Auditors

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications &

event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Management Controls Under QSR and ISO 13485 -Webinar By GlobalCompliancePanel  

Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in...

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