Live eLearning - PDA 743 Modern Thermal Validation Using Real Time Wireless Dataloggers

Cesar Mirabal advises life sciences organizations on how to achieve value through regulatory compliance. He has an engineering background coupled with a Master's Degree in Management and certifications as Six Sigma Black Belt and Certified Manager of Quality/Operational Excellence, and over 25 years of experience in project management, validation, and regulatory compliance, quality assurance, calibration & maintenance and continuous improvement. He has extensive experience with facilities, utilities, manufacturing equipment and support systems, including thermal validation, computer system validation, technology transfer, commissioning, start-up, qualification and validation. His previous experience at Bayer AG, Alcon Laboratories, Johnson and Johnson, Mentor Technical Group, PSC Biotech and Pharma-Bio Serv includes roles as Engineer, Supervisor, Manager, Director, Managing Director and General Manager.

Quy has a B.S. in Biophysics from UCLA and is on the board committee for the ISPE Los Angeles Chapter. He has 10+ years of experience in the biotechnology and pharmaceutical industry, holding positions in Quality, analytical chemistry, and drug product process development. As a Lab Manager at Amgen, he oversaw the procurement, qualification, and maintenance of equipment and analytical tools. Now with Lives International, Quy is focused on ushering a new era for thermal validation incorporating new technologies to address the globalization and harmonization of pharmaceutical manufacturing standards.