Published Articles
Ensuring the Supply Chain through Purchasing Controls
The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished...
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Published Articles
Fundamentals of Batch Recovery Procedures
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...
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Blogs
The Streamlined Approach to Combination Product Compliance
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,...
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Published Articles
Audits, Inspections, and CDMOs
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...
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Published Articles
Ask the Expert: Commenting on Draft Regulations
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...
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Webinars
Data Integrity in the Age of AI: Securing Connected Devices
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...
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