Resources

Explore our extensive resources to uncover more about RCA's expertise in life sciences consulting.

Content Type

Segment

Industries

Podcasts

Warning Letter Remediation

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates® Executive VP of Pharmaceuticals, Steven Lynn, go over how RCA helped an international company perform a gap...
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Podcasts

Quality Management System

In this episode of RCA Radio, guest host Dean Coston and Susan Schniepp, Regulatory Compliance Associates Inc.'s (RCA) Distinguished fellow go over how the people, processes, and documentation all come...
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Case Studies

Strategy for Pharmaceutical Submission

A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. RCA suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining...
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Case Studies

21 CFR Part 11 Gap Analysis

RCA was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory...
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Podcasts

Protocol Design for Biologics

In this episode of RCA Radio, host Brandon Miller, Steve Lynn, Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, and Walter Mason, RCA's Sr. Director of Quality Control and...
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Podcasts

2021 Industry Outlook – Pharmaceuticals

In this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates (RCA) Executive VP of Pharmaceuticals, provide an outlook into the most important things...
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