25 episodes

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

RCA Radio Regulatory Compliance Associates

    • Arts
    • 5.0 • 11 Ratings

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

    DHF & Design Control

    DHF & Design Control

    In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF for your Medical Device products.
    Jessica has over 20 years of experience in medical product development. She started her career in a medical device startup, working directly with physicians and end users to develop a bleeding edge surgery system. Since then, her work experience has spanned combination products, sterile implants, sterile disposables, capital equipment, and instrumentation at all phases of development. She is currently one of RCA’s Quality subject matter experts in helping clients create and improve their design history files as well as the entire Quality Management System.
    Listen in as Jessica goes over the trends we as consultants are seeing, how experts can help in the process, the first steps in getting the right help, and finish off with some major pitfalls clients face during the DHF process.
    About RCA
    Regulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    • 14 min
    What is Irritation and Sensitization?

    What is Irritation and Sensitization?

    In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Audrey is a Nelson Labs Senior Biocompatibility Expert.

    Listen in as Matt and Audrey help educate our listers about Irritation and Sensitization in medical devices biocompatibility for launching your products in this part of the Intro into Biocompatblity podcast series.
    About RCA
    Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    Pharmaceutical Biologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    About Nelson Labs
    Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
    Companies choose Nelson Labs for our:
    Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.Customer-centric culture. We take the time to understand your vision. Your goals become our goals.Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.Metric-driven testing processes. We’re our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.See how we can help you mitigate risk, be first to market, and succeed with your customers.

    • 27 min
    Outsourcing and Staff Augmentation

    Outsourcing and Staff Augmentation

    In this episode of RCA Radio, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates® (RCA), to going to over outsourcing leadership roles and how companies use staff augmentation to jump-start their teams.
    Listen in as we talk about what outsourced leadership and staff augmentation are by providing brief background and current trends in the industry. Then move on to talk about the process of augmenting your staff, the benefits, and why having a subject matter expert is critical in these types of projects.

    About RCA
    Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    • 14 min
    What is ISO 13485?

    What is ISO 13485?

    In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry.
    Listen in as Jordan goes over the background of the ISO standard as well as some useful information companies can use when preparing to implement or update the standard.
    He also touches on the current proposed amendments by the FDA. If you would like to submit comments or schedule a meeting with Jordan to discuss these proposed changes, please follow this link to our contact us page to set up a meeting. 
    About RCA
    RCA provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    • 13 min
    What is Cytotoxicity?

    What is Cytotoxicity?

    In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph.D. in cell biology.

    Listen in as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices by taking a deep dive into cytotoxicity testing of medical devices in this part of the Intro into Biocompatblity podcast series.

    About RCA
    Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    About Nelson Labs
    Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
    Companies choose Nelson Labs for our:
    Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.Customer-centric culture. We take the time to understand your vision. Your goals become our goals.Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.Metric-driven testing processes. We’re our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.See how we can help you mitigate risk, be first to market, and succeed with your customers.
     

    • 30 min
    2022 Industry Outlook - Pharmaceutical

    2022 Industry Outlook - Pharmaceutical

    In this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates® Inc.  (RCA) Executive VP of Pharmaceuticals, explore what is happening in the Pharmaceutical industry in 2022  and provide you with insight on how to prepare yourself for these upcoming initiatives.

    Listen in as we go over the increase in spending in the industry as a whole, the continued expansion of cell and gene therapies, mRNA technologies, virtual manufacturers, virtual inspections, ongoing supply chain issues, and the compliance hurricane that is forming.

    About RCA
    Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
    PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
    As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    • 22 min

Customer Reviews

5.0 out of 5
11 Ratings

11 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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