Regulated businesses are realizing the powerful benefits that an eQMS offers. But they don’t always consider how to weave digital quality management into their operational plans, leaving eQMS investments as an afterthought or — worse still — a frantic last-minute response to their regulatory audit findings.
This webinar breaks down how to organically integrate electronic quality management into a business strategy, pinpointing the perfect time to digitize a quality approach.
Register and learn about using eQMS approaches to set up a business for long-term success.
Eric Day, Director of Quality Assurance, Expression Manufacturing LLC, a subsidiary of Expression Therapeutics Inc.
Eric received a BS Degree from Miami University. He has over 25 years of experience in quality assurance, records management and training and development within the pharmaceutical industry. His work experience includes: cGCP and cGMP compliance, regulatory agency audits, IRB audits, sponsor audits, investigative site audits, internal system audits, root cause analysis, trial master file records management, source data collection and review, SOP development and staff training. Eric has been at EMLLC since June 2020 where he is the Director of Quality Assurance.
William Swaney, President, Expression Manufacturing LLC, a subsidiary of Expression Therapeutics Inc.
William is a senior biotechnology professional with over 15 years experience in biopharmaceutical manufacturing. He is competent in the manufacture, testing, certification and use of viral vectors & expanded autologous bone marrow derived human mesenchymal stem cells for use in early Phase I/II clinical trials. His relevant experience includes basic molecular biology techniques, cell culture, manufacturing process development, development and qualification of quality control assays, regulatory support, quality assurance and management.
William is a successful leader, team builder and motivator. He has been effective in distilling complex situations or procedures of a technical, regulatory, or business nature to a defined set of core issues which can be readily addressed in an action plan. His breadth of technical expertise include, process development, Tangential Flow Filtration (TFF), mammalian cell culture, viral vector production platforms, operation of Wave Bioreactor and quality assurance and regulatory attributes for cell and gene therapy products.
Meg Sinclair, Manager of Quality Operations, Qualio
Meg has 10+ years as a Quality Assurance, Regulatory Affairs, and Compliance professional with a range of cross-functional skills and experience spanning non-profits to start-ups. Meg helps companies adapt to and master new and complex subject material with organization and attention to detail.
Who Should Attend?
- Quality Assurance
- Regulatory Affairs
- Clinical Operations
- Product Managers
What You Will Learn
- Learn the optimal point in business journey to ditch paper and spreadsheets and move to an eQMS
- Explore when a QMS and eQMS become unavoidable steps on the business pathway
- Dive into common mistakes businesses make with their evolution to digital quality
Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.