Resources

The evolving landscape of supplier quality in the life sciences industry is shaped by globalization, outsourcing, and heightened regulatory demands. A risk-managed approach to supplier quality is essential, enabling manufacturers...

Q. I am a small-scale parenteral manufacturer and have been approached to support a clinical program through Phases II and III. What sterile manufacturing considerations are important for the small-scale...

Q: I am in the quality assurance department at my company. We are a small start-up, and one of my jobs is to develop a quality risk management plan. Can...

MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements...

Client Challenge A global pharmaceutical and medical device company faced challenges in scaling its workforce to meet the demands of rapid business growth and increasing regulatory oversight. Specifically, the company...

Q: I am a quality control (QC) manager of a contract test laboratory. I am going to be upgrading the lab testing environment and would like to know if you...