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 ÃÛ¶¹ÊÓƵ Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, ÃÛ¶¹ÊÓƵ Affairs at ÃÛ¶¹ÊÓƵ 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 ÃÛ¶¹ÊÓƵ 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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