Resources

Insights on driving value from staffing, automation and continuous improvement. Developing a quality management system is the foundation for ensuring the organization’s products or services are safe, effective and controlled...

Q: I saw where FDA released draft guidance on data integrity. In the guidance, the answer to question 16 says personnel should receive cGMP training to detect data integrity issues...

Lisa L. Michels, General Counsel and regulatory affairs expert at Regulatory Compliance Associates® Inc., discusses how the global medical device regulatory landscape is impacted by international law. The global medical...

By Seyed Khorashahi, MSc, and Mark Agostino, MSc The purpose of this article is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry. The...

Regulatory Compliance Associates® (RCA) Distinguished Fellow, Susan Schniepp discusses establishing a quality culture from the top of an organization down. Quality culture is a patient-focused approach to quality that is...

Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic technique during processing. Recently, the facility has experienced an increase in the...