Impact of COVID-19 on GXP Inspection Practices скачать в хорошем качестве

Impact of COVID-19 on GXP Inspection Practices

This week, Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding how these elements affect our inspection preparedness, as well as our day-of-audit activities, is critical to a successful site visit. Be prepared for virtual site visits and audits to become the norm. About Our Guest: Kelly Simpliciano Associate Director, Research Development Quality - Clinical Trials Systems & Auditing QA Bristol-Myers Squibb. Kelly has been with Bristol-Myers Squibb since 2003 when she joined as a QA analyst. Kelly achieved her MS, Quality Assurance and Regulatory Affairs in 2018. 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.  This episode is brought to you by IVT Network's Validation Week. #COVID19 #IVTNetwork #VirtualWeek