Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid ...

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems. The current International Council for Harmonisation (ICH) Q9 ...

Editor's Note: "Rebalancing Quality Priorities" is a three-part series describing a new approach to quality management from a customer and risk management perspective that involves the entire ...

Build it. Develop it. Improve it. Your business needs a sustainable risk management framework that is as forward-thinking as ...

New Delhi: The Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also ...

Pharmaceutical Inspection Co-Operation Scheme (PICS) has come out with recommendations on how to demonstrate effectiveness of pharmaceutical quality system (PQS) in relation to risk based change ...

Editor’s note: This article is the first in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. In June 2022, the AICPA’s Auditing ...

The Quality, Safety and Risk Management in Healthcare prepares you to lead organizational efforts that improve and monitor quality metrics, improve safety for both patients and staff, and manage risks ...