United Podcast Network
COVID-19 and the Increased Demand for Personal Protective Equipment
Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic.This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/downloadTopics Include:How can we converse masks and respirators while demand is high?Will the influx of new masks and respirators be up to FDA standards?What is the FDA doing to halt counterfeit respirators?Will the quality of medical devices go down during this time?Is the US too late to effectively handle the demand?What are companies doing to conserve their products right now?How does this pandemic effect reliability testing?What will be the long term impact on medical device companies?Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Duration: 36 min