Webinars
End-to-End Human Factors for Medical Devices and Re-processing Usability Testing
Human Factors Engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world use. Join Regulatory Compliance Associates (RCA) and Nelson Labs for...
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Published Articles
Ensuring the Supply Chain through Purchasing Controls
Building a Secure and Resilient Pharmaceutical Supply Chain In this article, Jane Zhang, Co-Founder and Co-CEO of ETCH Sourcing, and Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson...
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Published Articles
Fundamentals of Batch Recovery Procedures
Pharmaceutical Batch Recovery Procedures In this article, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, discusses best practices for recovering pharmaceutical manufacturing batches following production deviations....
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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
Preparing CDMOs and Sponsors for Regulatory Inspections For contract development and manufacturing organizations (CDMOs), navigating regulatory inspections can become complex when multiple clients have different specifications, requirements, and expectations. While...
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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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