RCA Radio Regulatory Compliance Associates

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.

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.

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.

Listen in as we address how the FDA performs virtual audits and inspections, some best practices for conduction these audits and inspections, as well as how companies can prepare for this type of remote work.

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.