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 a 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 and establishment of a quality policy. It will also discuss the steps to confirm whether the requirements are being followed, establishment and contents of a quality system and quality plan, and all aspects of management reviews.

Objectives of the Presentation

• QSR and ISO 13485 requirements for management controls

• Organizational structure

• Establishment of an internal audit program

• Establishment of your company's quality policy

• Quality plan vs. quality objectives

• Management reviews: Getting the most bang for your buck

• Changes to ISO 13485:2021

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Why Should you Attend

Management controls is much more than merely management review. Many more systems must be in place to assure your firm is in compliance with the regulations. Top management must be directly involved in the QMS. This webinar will provide proven interpretive practices that have been determined to be in compliance with the regulations, and hints on how to utilize management controls on a routine basis.

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to assure there are adequate management controls in place in their quality management system. This course will also help ensure that quality system functions acceptably and is fully sanctioned by and communicated to top management. Lastly, this session will cover applicable changes to ISO 13485:2021.

Who will Benefit

This webinar will provide valuable assistance to all companies who have ISO certification or are registered with FDA, across the medical device, diagnostic, pharmaceutical, and biologics fields.
The employees who will benefit include:

• Executive management

• Regulatory management

• Regulatory affairs and quality assurance professionals

• Consultants

• Sales/marketing management

• Senior and mid-level management

• Quality system auditors

Instructor Profile

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC.


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