Improving the quality of clinical trials is a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements can have a positive impact on the ...

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met. Quality risk management (QRM) is being performed more frequently in the ...

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data ...

Navigating the intricacies of compliance and risk management can seem overwhelming for businesses, especially those operating in heavily regulated industries. The rules are complex and the stakes are ...

In June 2022, the AICPA’s Auditing Standards Board (ASB) and Accounting and Review Services Committee (ARSC) issued interrelated final standards on quality management intended to clarify and improve ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements. Participants will learn how to ...

Stopping using tobacco reduces the risks of developing tobacco-related illnesses or worsening conditions affected by its use, however some people may not want, or be ready, to stop in one go. It is ...