Compliant Management Controls Under 21 CFR 820 and ISO 13485

03:00 PM ET | 12:00 PM PT | 04:00 PM CT Duration 60 Minutes

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

"Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management"

Quality system functions acceptably and is fully sanctioned by and communicated

Description

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.

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 13485:2016.

Areas Covered

•       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 13485:2016

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

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . 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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