This week, Stacey welcomes back Chris Wubbolt to get a better understanding of the unique data integrity and validation oversight needed in virtual environments in a post-pandemic world. Stacey and Chris discuss the challenges for businesses of all sizes whether they use a hybrid or remote model.

Resources From This Episode:

FDA Provides Guidance on Remote Interactive Evaluations

COVID-19 - US Food and Drug Administration Guidelines

IVT's Annual Computer Systems Validation and Software Assurance Week Compendia

Chris Wubbolt, Principal, QACV Consulting

Chris has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training, and quality improvement processes. Prior to becoming a consultant, Chris worked in Computer Systems Validation and Quality Assurance roles for Aventis Pasteur, Johnson & Johnson’s McNeil Consumer Products Company, and Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Chris can be reached by email at Chris Wubbolt [email protected]

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