Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
Join us for a webinar on March 25 for a discussion of the webinar.
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
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors
- 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
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.
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.