RCA Radio

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 & Biotechnology
• Sterile compounding
• Medical device

We 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.

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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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.

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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device

We 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.