12 episodes

RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. Each episode, join Regulatory Compliance Associates® Inc. (RCA) and industry thought leaders as we navigate the issues that matter to you most.

RCA Radio Regulatory Compliance Associates

    • Arts
    • 5.0 • 10 Ratings

RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. Each episode, join Regulatory Compliance Associates® Inc. (RCA) and industry thought leaders as we navigate the issues that matter to you most.

    2021 Industry Outlook - Pharmaceuticals

    2021 Industry Outlook - Pharmaceuticals

    Listen in as we go over the importance of these Pharmaceutical incentives, some of the potential problems companies are facing during implementation, and some alternatives to mitigate those problems.

    • 28 min
    2021 Industry Outlook - Medical Device

    2021 Industry Outlook - Medical Device

    In this episode of RCA Radio, host Brandon Miller and Seyed Khorashahi, who is Regulatory Compliance Associates (RCA) Executive VP of Medical Device and CTO, provide an outlook into the most important things happening in 2021 to the medical device industry such as; Brexit, the European Medical Device Regulations (EU MDR), In Vitro Diagnostic Regulation (IVDR), General Data protection regulation (GDPR), unique device identifier (UDI), and the European Databank on Medical Devices (EUDAMED).  
    Listen in as we go over the importance of these medical device incentives, some of the potential problems companies are facing during implementation, and some alternatives to mitigate those problems.

    • 30 min
    Data Integrity and Quality Culture During the Pandemic

    Data Integrity and Quality Culture During the Pandemic

    Listen in as we address why Data Integrity and Quality Culture are so important, permanent changes as a result of the pandemic, how to leverage the changes, and how it is all related to having a good quality culture.

    • 28 min
    Virtual Audits and Inspections

    Virtual Audits and Inspections

    Listen in as we address how the FDA performs virtual audits and inspections, some best practices for conduction these audits and inspections, as well as how companies can prepare for this type of remote work.

    • 24 min
    Aging Facilities and In-Shoring Product to the US

    Aging Facilities and In-Shoring Product to the US

    Listen in as we address the considerations that manufacturers should take into account when evaluating these In-Shoring projects and the risk-based approach that the FDA is taking for evaluating site inspections.

    • 38 min
    Supply Chain Risk Management

    Supply Chain Risk Management

    With manufacturers in the United States and around the world facing problems with their supply chains, it is important to know how to identify and mitigate the risks involved. In this episode of RCA Radio, host Erika Porcelli and guest Larry Servi, Regulatory Compliance Associates (RCA) Director of Program Management, to discuss how companies can tighten their Risk Management to help mitigate the potential risks that hurt supply chains. 

    Listen in as we address the benefits of having multiple sources for your supply chain and things that can be done to help reduce and relax the qualification requirements. 

    • 14 min

Customer Reviews

5.0 out of 5
10 Ratings

10 Ratings

MasterCheif101 ,

Very informative!!!

I wasn’t familiar with Sue or her background prior to joining RCA and I found this podcast extremely enlightening in providing a lot of the How to demonstrate and document integrity of your data as well as how to establish and drive a quality culture. Anybody involved in the pharmaceutical industry would benefit from listening.

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