Dr. Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.
Dan Modi, M.B.A., RAC, has 25+ years’ experience in Standards Certification, Regulatory Documentation and Design Control requirements for medical devices. Modi is certified as RAC (Regulatory Affairs Certification), NCE (NARTE Certified Engineer) and CQA (Certified Quality Auditor through the American Society for Quality-ASQ). He was Director of Regulatory Certification, responsible for Design Quality and Regulatory Certification at Alcon Research Ltd., a division of Novartis. He has wide experience working with simple to complex electro-medical products and in supporting small start-ups to fortune 500 companies over the years.
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
|Event||Date||Day||Start Time||End Time||Location||Room
|START||09/19/2022||Monday||---||---||Online (Access Begins)||---
|OL-LEC||10/11/2022||Tuesday||7:00 PM||8:00 PM||Zoom||---
|OL-LEC||10/18/2022||Tuesday||7:00 PM||8:00 PM||Zoom||---
|END||11/27/2022||Sunday||---||---||Online (Access Ends)||---