Quality management is an integral factor in the development, approval, and commercialization of medical devices. With the American Medical Device Summit approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana.
As Vice President of Regulatory and Product Management, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, and regulators, as well as Pilgrim’s Development, Professional Services, and Support groups, Kari and her team are responsible for translating market and industry trends, along with customer and regulatory requirements, into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. Additionally, Kari leads the development of user documentation and solution presentations. Working with Pilgrim’s Customer Product Advisory Board, Kari is responsible for the company’s product roadmap, product partner relationships, and overall product direction.
Questions answered:
- What is the current state of the regulatory and quality landscape for Life Sciences organizations?
- Pilgrim assists companies in achieving a “Quality Nirvana.” What is a quality nirvana and why should life science organizations strive to achieve it?
- What are the most common hurdles that organizations have to overcome to achieve this nirvana?
- In your opinion, how can companies best enable cultural change to achieve a quality-driven/focused culture?
- What is a “single source of quality truth” and how does it help to mitigate risks or identify opportunities?
- If you had to give one piece of advice to someone looking to implement an Enterprise QMS, what would it be?
- How do you see the quality needs of the Life Sciences industry evolving over the next five years?
Click through to read the interview and find out how to build your Quality Nirvana.
