RCA Radio

In this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates® (RCA) to talk about outsourced technical program management and the increased demand caused by the shortage of qualified subject matter experts. Listen in as Eric goes over what outsourced program management is, the benefits clients receive when having a technical program manager, and the heuristic approach RCA takes with their program managers to transfer knowledge to the clients internal team. 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 regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

In this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve is Regulatory Compliance Associates® (RCA) Executive Pharmaceutical Consultant and Susan is the chair of PDA and as well as a Distinguished Fellow at RCA. Listen in as we go over the increase in spending in the industry as a whole, the continued expansion of cell and gene therapies, drug and device combination products for home and office use, cybersecurity in combination products, non-life science company’s getting into the pharma industry, data integrity and compliance issues, vaccine development with the expansion of mRNA technologies, the post pandemic shift of 503b compounders, and finally the cultural shift around retiring. 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.

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.

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: approachable expertstesting accuracycompliance expertiseSee how we can help you mitigate risk, be first to market, and succeed with your customers.

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.

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.

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: approachable expertstesting accuracycompliance expertiseSee how we can help you mitigate risk, be first to market, and succeed with your customers.

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.

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. We cover the basic background of pre-clinical testing, explore the new things happening in the field, go over some best practices for testing, and then end with some advice on picking a testing lab for yourself. 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.

In this episode of RCA Radio, host Brandon Miller, Seyed Khorashahi, and Thor Rollins explore what is happening in the medical device industry in 2022 and provide you with insight on how to prepare yourself for these upcoming initiatives. Seyed is Regulatory Compliance Associates® Inc. (RCA) Executive VP of Medical Device and CTO. Thor is Nelsons Laboratory’s Toxicology, and Extractables and leachables (E&L) Expert. Listen in as we provide an outlook into the most important things happening in 2022 to the medical device industry such as; New technology uses cases, new notified body regulations, upcoming onsite inspections, supply chain issues, and much more. 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.

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, take a deep dive into laboratory Out-of-Specification (OOS) investigations and how to get to the root cause. Listen in as we go over best practices for dealing with laboratory OOS investigations, relevant guidance documents, and a few examples from warning letters that are available to the public. 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.

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, go over a case study where we tried to teach a client that received a warning letter life lessons for Quality Complaint investigations. Listen in as we break down how we helped this client and taught them an important life lesson for the industry while addressing their Quality Complaint warning letter. 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.

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations. Listen in as we break down the client's Warning Letter Remediation challenges, RCA's approach to remediation, the ongoing work still taking place, and some advice on FDA Investigation Readiness. Stay tuned for Part 2 of this case study once we have completed the entire project. 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.

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 together to make a Quality Management System. 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.

In this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data, and the different methods of analyzing data. 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.

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 happening in 2021 to the Pharmaceutical industry such as; timeliness in regards to vaccines and EUAs, virtual inspections, cellular and gene therapy, facility modernization, data integrity, the idea of the modern quality professional, data collection, knowledge management, and pharmacy compounding. 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. 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.

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. 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.

Among the current and emerging topics of interest to the pharmaceutical industry, the topics of quality metrics, quality culture, and data integrity are of particular concern to both the industry and the regulatory authorities. In this episode of RCA Radio, host Brandon Miller and guests Steven Lynn, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, and Susan Schniepp, RCA's Distinguished Fellow, discuss why Data Integrity and Quality Culture are more important now than ever before. 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.

Companies in almost every industry across the world have had to adjust due to the pandemic by moving key face-to-face activities into a virtual platform. In this episode of RCA Radio, host Brandon Miller and guest Steven Lynn, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, discuss Virtual Audits and Inspections. Listen in as we address how the FDA performs virtual audits and inspections, some best practices for conducting these audits and inspections, as well as how companies can prepare for this type of remote work.

Companies across the United States and around the world currently evaluating their supply chains as well as in-sourcing their manufacturing needs. In this episode of RCA Radio, host Erika Porcelli and guest Brendan McCrea, Regulatory Compliance Associates (RCA) Director of Validation Program Management, discuss how companies can update their aging facilities and the benefits of In-Shoring products. 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.