Live Webinar Management Controls Under FDA QSR and ISO 13485

1:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Hear By Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management"


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.

Areas Covered

•    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

Who will Benefit

•    Top Management
•    Regulatory Management
•    Quality Assurance Professionals
•    Consultants
•    Sales/Marketing Management
•    Senior and mid-level Management
•    Quality System Auditors

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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