Resources

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...

As connected medical devices become more prevalent, cybersecurity regulations are evolving rapidly across global markets. Manufacturers must now navigate complex requirements from both the United States Food and Drug Administration...

With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This whitepaper offers a focused look at preparing your facility, emphasizing internal audits and...

This white paper presents a detailed roadmap for compounding pharmacies aiming to transition from a 503A patient-specific model to a 503B outsourcing facility. It explores the strategic planning, facility design,...