Event Detail
Management Controls Under QSR and ISO 13485 - Webinar By GlobalCompliancePanel
August 23, 2012 - Wilmington DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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 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 plan, and of course all aspects of management reviews. Areas Covered In the Seminar: 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 Who will benefit: Regulatory Management Quality Assurance Professionals Consultants Sales/Marketing Management Senior and mid-level Management Quality System Auditors 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. Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00 Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com