On-going Success Stories at BIOVECTRA Using NuGenesis LMS

BIOVECTRA is a biotech Contract Development and Manufacturing Organization (CDMO) located in Atlantic Canada serving customers in the pharma industry with phase-appropriate solutions from IND applications through clinical trials and commercial manufacturing. We will share BIOVECTRA's ongonig implementation of NuGenesis LMS and the success stories we've had along the way.

Presenter: Neeraj Mehta (Quality Systems Manager, BIOVECTRA)

Neeraj Mehta is a Quality Systems Manager with BIOVECTRA in Canada. Neeraj is responsible for the development and maintenance of Electronic Quality Management Systems. Prior to joining BIOVECTRA in 2019, Neeraj worked in a diagnostics company in the UK as a Quality and Regulatory Affairs Manager, where he implemented and maintained a quality management system compliant with ISO13485:2016, ISO14971, and FDA 21CRF820.

Presenter: Brendan Sheppard (Program Coordinator, BIOVECTRA)

Brendan Sheppard is a Program Coordinator at BIOVECTRA in Canada where he serves as the subject matter expert for NuGenesis LMS. He is responsible for the development, implementation, validation, and end-user training for all NuGenesis workflows. Prior to this, he worked as an Analytical Chemist where he worked extensively with Empower gaining familiarity in method development, custom fields, and report customization.

HOST: Victoria V. Lander (Americas Contract Organization Marketing Manager, Waters Corporation)

Victoria Lander is currently the Americas Contract Organization Marketing Manager at Waters Corporation (Milford, MA). She is responsible for marketing and market development for enabling scientific technologies focused on the pharmaceutical and biopharmaceutical industries. Victoria also participated in the PDA 21 CFR Part 11 Task Group (adjourned) and the ‘Information Assurance’ Task Group in Bethesda, MD, and has given many conference presentations on US FDA Regulatory Compliance issues. Victoria also had global Marketing Director roles for Bruker Daltonics and for Applied Biosystems/MDS SCIEX in where she managed a group responsible for the promotion and tactical marketing of analytical and medical device solutions. Victoria’s past experience included positions in Technical Sales, Applications Chemistry, Technical Training, and various research positions in mass spectrometry including those at the University of Arizona, Hoffmann LaRoche in Nutley, NJ and at the Mount Sinai Medical Center in NYC. Earlier biomedical research positions were also held at The Burke Rehabilitation Center in White Plains, NY and at American Cyanamid in Stamford, CT. She has also published extensively in the biology /biochemistry and compliance-related fields.

Victoria has an MS in Organizational Development from William James College, a BS in Biology, and a BA in Psychology from Purdue University.