With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are grappling with significant challenges in maintaining their supply chains. In this episode, host Erika Porcelli is joined by Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parenteral Drug Association (PDA) Chair-Elect, and Lisa Michels, RCA’s General Counsel & Regulatory Affairs Expert, to discuss the regulatory impacts and strategies to overcome these obstacles.
Erika, Susan, and Lisa delve into the implications of Emergency Use Authorizations (EUAs) during the pandemic. They explore how the expedited approval process has affected the regulatory landscape, enabling faster access to essential medical products while ensuring safety and efficacy. The discussion provides valuable insights into navigating the complexities of EUAs and their long-term impacts on the industry.
The episode also addresses the new distancing regulations implemented to combat the spread of Covid-19. Susan and Lisa share practical advice on how manufacturers can adapt to these measures while maintaining compliance with regulatory standards. They discuss innovative approaches to managing operations under the constraints of social distancing, emphasizing the importance of flexibility and resilience in these unprecedented times.
Listeners will gain a comprehensive understanding of the FDA’s long-term inspection strategy moving forward. The hosts outline the key components of this strategy, highlighting the shift towards remote and virtual inspections and the potential implications for manufacturers. By staying informed about these changes, companies can better prepare for future regulatory assessments and ensure continuous compliance.
This episode is essential for professionals in the pharmaceutical and medical device industries seeking to navigate the regulatory challenges posed by the Covid-19 pandemic. Tune in to learn about the expedited approvals, regulatory impacts, and strategies to overcome the operational hurdles brought about by the crisis.