Michael Barkan has extensive experience in quality management and validation within the pharmaceutical and laboratory informatics sectors. Currently serving as Quality Director and Delivery Manager at CSols Inc. since October 2015, Michael is responsible for corporate CAPA, investigations, and metrics, while providing guidance on data integrity adhering to GAMP and 21CFR part 11 regulations. Prior roles include Quality Manager and Validation Technical Lead, overseeing high-risk projects in laboratory informatics implementations, and serving as a Senior Informatics Consultant, where Michael authored Empower 3 SOPs and conducted validation testing. Previously, at Johnson & Johnson, Michael held the position of Principal Scientist-Group Leader, managing global computer system validation for the Consumer sector and deploying the Empower 3 Global R&D Lab Chromatography System. Michael's career began at Best Foods as a Scientist, after earning a Master's degree in Chemistry and Computer Science from the University at Buffalo.