Dot Compliance

DECEMBER 7, 2022

Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. Quality Management System Development 7. What is Quality Management System (QMS)? Systems for managing quality concerns, enhancing product performance, reducing waste, and driving continuous improvement are all provided by quality management systems.

FDA 52

FDA Compliance Records Management 52

SQA

OCTOBER 18, 2024

This precautionary measure adopted by the agency aims to ensure the health and physical integrity of the Brazilian population since, to date, no studies have been presented to ANVISA that prove the effectiveness and safety of the phenol product for use in such procedures. This only applies to sponsors who notified TGA before 25 May 2022.

FDA 52

FDA Compliance Public Health World Health 52

SQA

JUNE 3, 2024

The manual presents the concepts and procedures for the surveillance of adverse events related to transplants, grafts, and assisted human reproduction. Additional findings included concerns with respect to document control, records management, and lack of compliance with Standard Operating Procedures (SOPs).

FDA 40

FDA COVID-19 Licensing Nurses 40

SQA

OCTOBER 18, 2024

This precautionary measure adopted by the agency aims to ensure the health and physical integrity of the Brazilian population since, to date, no studies have been presented to ANVISA that prove the effectiveness and safety of the phenol product for use in such procedures. This only applies tosponsors who notified TGA before 25 May 2022.

FDA 40

FDA Compliance Public Health Governance 40