RCA Radio

 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:

• 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, 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:

• 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 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:

• 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 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:

• 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.

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. 

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. 

 With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains intact. In this episode of RCA Radio, host Erika Porcelli and guests Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, and Lisa Michels, RCA's General Counsel & Regulatory Affairs Expert, continue to discuss the regulatory impacts with Emergency Use Authorizations as well as how to address and try to overcome the new distancing regulations put in place to combat the spread of Covid-19.

Listen in as we go over expedited approvals and relevant regulatory impacts as well as the FDA's long term inspection strategy moving forward. 

With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains in tacked. In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, discuss the problems these companies are facing and how to address and try to overcome the new distancing regulations put in place to combat the spread of Covid-19.

Listen in as we go over Audits Effectiveness and Oversight of Service Providers and break down the different ways companies can work virtually to get audits done successfully. The challenges with recording audit findings and conducting interviews. What companies can do to audit suppliers and maintaining their supply chains. As well as answer the questions; is virtual auditing going to be a long term solution, and what companies can do to maintain oversight of service providers.