Resources

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...

Updating an Aging Facility Manufacturing line upgrades can create uncertainty for contract manufacturing organizations (CMOs) and their pharmaceutical clients, particularly when clients assume that any facility or equipment change requires...