Best in class biotech facilities are currently achieving paperless operations and building a roadmap towards predictive capability. What do paperless operations look like today? How do I move my facility towards a paperless operation and what do the predictive capabilities of tomorrow bring?
Panelist: Joseph Micsko. Global Director, PMT, CAI
Joe leads CAI’s Process Manufacturing Technology business area and is an Engineering SME. He oversees various projects for Biotech/Pharma clients. He has a wealth of knowledge and experience with over sixteen (16) years in the Pharma/Biotech Industry especially in Single Use Technology (SUT) and Cell and Gene Therapy (C>) Startups. Joseph manages the development and implementation of process improvements designed to achieve greater efficiency in overall Business Operations. He is a subject matter expert in CIP systems, Chemical Distribution Skids, Upstream and Downstream Processing, Single use systems, Autoclaves and Steam-in-Place (SIP). He has extensive knowledge of planning, coordinating, and executing Cleaning Validation Programs to verify compliance and absence of cross-contamination. Joseph has experience with Quality Risk Management (QRM) specifically in process risk and control strategies. He has successfully managed and led diverse teams across the globe delivering numerous Pharma/Biotech projects.
Panelist: Jonathan Thompson, Principal Consultant, CAI
Jon is a Principal Consultant with CAI who has over 20 years of experience in the Life Sciences. In his 20 years he has worked in the Aseptic Pharmaceutical and Biotechnology space to optimize customers’ operational processes and implement digital solutions to meet regulatory requirements. He has led global programs to standardize automated processes across a network of manufacturing facilities and small scale implementations such as a workflow process to automate Engineering Change Requests. He has helped small, clinical scale biotech companies define a digital roadmap to guide them into Operational Readiness and helped some of the world’s largest pharmaceutical companies define digital solutions move their operations into the Pharma 4.0 era. Jon’s mission is to deliver compliant digital solutions and expand digital capabilities to solve his customers business problems.