The top management of a company is responsible for ensuring that all regulatory requirements are met.
This key concept is codified in both the FDA 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 compliance 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 best practices to confirm it is communicated and understood, the relationship between a quality plan and quality objectives, establishment and contents of a quality plan, and how to assure your management reviews are meaningful. This session will also include practices to make sure management review is more than just a necessary evil, but an excellent communication tool.
- QSR and ISO 13485 requirements for management controls
- Organizational structure
- Establishment of an internal audit program
- Your quality policy: Communication and understanding
- Quality plan vs. quality objectives, and contents of your quality plan
- How to make your management reviews worthwhile
Director of Quality ,
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- Top Management
- Regulatory Management
- Quality Assurance Professionals
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors