Webinars
Always Inspection-Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This webinar offers a focused look at preparing your facility, emphasizing internal audits and...
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Blogs
FDA Expands Unannounced Inspections for Foreign Manufacturing Facilities
Regulatory Compliance Associates® (RCA) Executive Pharma Compliance Expert & Principal Consultant, Anita Michael, recently shared important FDA updates impacting pharmaceutical manufacturers. With over 25 years of global regulatory and quality...
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White Papers
Design and Development Files for Connected Medical Devices
In today’s rapidly evolving healthcare landscape, connected medical devices—those that transmit, receive, or act on data—represent some of the most innovative yet complex tools entering the market. These products, often...
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Podcasts
Cybersecurity Challenges in Connected Medical Devices
In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI Group to unpack the evolving...
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Case Studies
Integrating Device Design into a Biosimilar Program
Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical trials with a biosimilar product. While their drug development and...
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Webinars
Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch for an in-depth exploration of PDA/ANSI Standard 06-2025: Assessment of Quality Culture, a...
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