Upcoming Webinar - Thursday, July 16 at 11am PT / 2pm ET
Start-up life science companies often develop their Quality Management System (QMS) from the bottom up, creating SOPs and policies as needed throughout the company’s R&D and clinical stages. This organic approach, although convenient, will not produce a QMS that is cohesive, integrated or strategically aligned with the company’s long-term plans. The frequent result is gaps in essential coverage, a web of unworkable complexity, or both. These issues tend to become more limiting as the company approaches its commercial stage. In 2019, the deficiencies that the FDA identified most frequently during inspections were directly related to omission of policy governance and procedures.
The discussion will include:
About the Presenters:
- Regulatory context of Quality Management Systems
- Key pitfalls to avoid in developing your Quality Management System
- Roadmap for building your Quality Management System framework
- Key benefits of developing a framework roadmap
- Recommendations for QMS framework approach
Roger Davy, Project Management Lead-Emerging Life Sciences
Roger has 18 years of operations and IT project management experience in both consulting and industry roles in the pharma, biotech, engineering, and semiconductor industries. Working with both small and large life sciences firms, he has managed successful projects to address operations, quality, compliance, and regulatory challenges. Roger has led small biopharmaceutical company teams through implementations of a wide variety of cloud-based enterprise IT solutions, supporting successful regulatory submissions and inspections. He has also managed post acquisition integration activities.
Chris Merriam-Leith, Program Manager-Emerging Life Sciences
Chris Merriam-Leith is a Program Manager with USDM who has 20 years’ experience working with regulated life sciences companies. He holds a M.S. degree in Regulatory Affairs of Drugs, Biologics and Medical Devices from Northeastern University. He is also Regulatory Affairs Certified (RAC) for the US and globally. He is completing a second MS degree in the Quality Assurance of Biopharmaceuticals. He is available to consult with your company to help you navigate the complex regulatory challenges that your firm may be navigating.