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Subscribe NewsletterManagement Controls Under QSR and ISO 13485
Product Id
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600064
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.
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 Session:
- 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