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Compliant Management Controls Under 21 CFR 820 and ISO 13485


Location: California, USA
From: 2021/03/25 10:30
To: 2021/03/25 11:30
Posted by: WCS Compliance

About this Event

Live Webinar on 25 March 2021 at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST

Duration 60 Minutes

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

Training 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.

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.

Webinar Takeaway
  • 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

Jeff Kasoff( 30+ Years of Experience)

Regulatory Compliance and Quality Assurance ► FDA QSR, ISO 13485/9001 ► Operational Excellence -Remote Consultations

York, Pennsylvania, United States

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 startup 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. Jeff 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.




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