Podcasts
503 Compounding: Challenges, Compliance & the Road Ahead
In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies....
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Case Studies
Strategic CGMP Remediation for a Major Pharmaceutical Company
In the highly regulated pharmaceutical industry, compliance with FDA regulations is paramount to ensuring product safety and overall quality. When a large pharmaceutical company received a Form FDA 483 and...
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Published Articles
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR...
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Published Articles
Ask the Expert: Complying with 21 CFR 211.110
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the...
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Published Articles
Drug Digest: Advances in Small-Molecule Manufacturing
In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief...
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Blogs
Understanding the Knowledge-Aided Assessment and Structured Application (KASA)
As regulatory processes evolve, the Knowledge-Aided Assessment and Structured Application (KASA) system is set to transform FDA application reviews through automation and structured data analysis. Designed to enhance efficiency and...
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