This week, Stacey welcomes back Ivan Soto to discuss how the pandemic has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. Downtime due to social distancing requirements, employee illness, and the close of many departments for on-site purposes have had a major impact on productivity and production. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enough to provide contingencies for all impacted functional areas. Today we will highlight strategies that enable validation leadership and teams to keep validation activities functional and productive not only throughout but following the pandemic.

Resources from this episode:

Keeping Validation Functional & Productive During A Pandemic - Article in Journal of Validation Technology, Vol. 26, Issue 6, December 2020

Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts - Article in Journal of Validation Technology, Vol. 26, Issue 4, August 2020

Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and has held several technical and management positions at different biotech and pharmaceutical companies in Validation, IT Compliance, Quality Control, Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.

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 

Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.


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