Compliant Management 2021 - Compliant Management Controls Under 21 CFR 820 and ISO 13485

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.
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.
QSR and ISO 13485 requirements for management controls
Organizational structure
Establishment of an internal audit program
Speaker:
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,