Resources

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing. Q: What is the best way to...

Understanding and Applying the Streamlined QMS Framework In today’s rapidly evolving life sciences landscape, pharmaceutical and biologic companies are increasingly venturing into the world of combination products. These innovative therapies,...

In this episode of the Ask the Expert video series hosted by Pharmaceutical Technology®, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how...

In this episode of the Ask the Expert video series published by Pharmaceutical Technology®, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those...

As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity is evolving rapidly. This webinar explores the intersection of cybersecurity, regulatory compliance, and...

As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic companies must adapt their existing Quality Management Systems (QMS) to meet regulatory expectations...