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There are clear applications and broad acceptance of augmented reality technologies in training departments, but the use of these systems as part of the inspection process has been limited. Virtual inspections have the capability to revolutionize how both client and regulatory inspections are conducted, especially during times of crisis and interruption to business continuity.
However, this technology (e.g. Microsoft HoloLens and Matterport 3D Mapping) is available today and can be widely used as the standard for inspections of the future. Strategies for implementing on-site virtual inspections will be discussed during this presentation.
SPEAKER: Monica M. Commerford, Ph.D., Manager, Regulatory Affairs, Brammer Bio
Monica M. Commerford, Ph.D., is currently the Manager of Regulatory Affairs at Brammer Bio in Cambridge, MA, part of Thermo Fisher Scientific. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER and performed pre-license inspections of biological product manufacturing facilities. In addition, she has participated in writing policies and a draft guidance document. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.
WHO SHOULD ATTEND THIS WEBINAR: Any person who participates in inspections including Quality, Regulatory, operations and management. Also, anyone interested in the use of emerging technologies including IT/OT specialists, Digital and Innovation leads.
REGISTRATION FEES: Member: FREE Non-Member: $15 Registration Deadline is Wednesday, July 8th at 5:00 pm.
LOG ON INFORMATION: Prior to the webinar a confirmation e-mail will be sent with the unique registration link to the webinar meeting room. Use the link to register on the GoToWebinar platform. Once your registration is approved, an additional confirmation e-mail with detailed information to use the day of the webinar will be sent to you.
The webinar can be accessed through phone, online, or through the webinar app. For more information, visit GoToWebinar’s FAQ page.
MEETING MANAGER: Megan Baillie, High Purity New England