Resources

Integrating Data Integrity Into Annual cGMP Training FDA’s guidance on data integrity reinforces the importance of ensuring personnel understand how to identify and prevent data integrity issues. But organizations do...

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...

Click now to listen to Regulatory Compliance Associates' executive principal consultant, pharma and biologics, Steven J. Lynn, MS, shares his thoughts about emerging therapies, expanding cell and gene therapies on...