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RCA Radio

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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 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.
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Location:

United States

Description:

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.

Twitter:

@RCAExperts

Language:

English


Episodes

Regulating Cannabis

11/1/2019
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From the legalization of recreational marijuana to the growing popularity of CBD-infused products, the cannabis industry is all abuzz in the United States. But how is it regulated? In this episode of RCA Radio, host Erika Porcelli and guest Neil Pankau, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, discuss this burgeoning industry, the regulatory framework governing it, anticipated regulatory developments at the federal and state level, and the FDA's...

Duration:00:27:59

Outsourcing Surveillance Activities

9/9/2019
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In this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a Regulatory Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance activities in both the medical device and pharmaceutical industries. Not recognized as a business strategy until the late 1980s, outsourcing is now looked at as a strategic partnership for businesses, growing increasingly in the U.S. with many key considerations at play. Listen in as we discuss a brief...

Duration:00:29:07

Data Integrity and Quality Culture

8/5/2019
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In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), examine the resurgence of data integrity issues and the focus of global regulatory agencies. With the recent rise in data integrity-related citations, global regulatory bodies including the FDA, MHRA, World Health Organization, and PIC/S, have released documents to reeducate the pharmaceutical industry on data integrity concepts. Many of these guidelines...

Duration:00:29:00

Artificial Intelligence & Machine Learning-Based Software as a Medical Device

6/3/2019
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In our first episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at Regulatory Compliance Associates (RCA), examine the FDA's proposed regulatory framework for modifications to artificial intelligence and machine learning (AI/ML)-based software as a medical device. We dive into the FDA discussion paper, what AI/ML software are and how they work in medical devices, and discuss how potential risk factors resulting from this software's...

Duration:00:36:31