To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the end patient to the investors benefit. A Harvard study on quality found that a “company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.” This webinar will show participants how to define their quality culture and help everyone on your team strive to improve it.
Register for this webinar to learn from quality experts from Qualio, 4G Clinical and others who have successfully built a quality culture. Participants will take away lessons for building a quality-driven culture that they can apply today.
Meg Sinclair, Senior Quality Specialist, 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.
Laura Araujo, Vice President - Quality, 4G Clinical
Laura Araujo brings years of leadership experience in the Pharma and Biotech industry in the areas of Quality, Regulatory and Information Technology and continues to be instrumental in her role as the Vice President of Quality at 4G Clinical. She has worked on the Sponsor, CRO and Technology Provider side in the industry for over 25 years. Prior to joining 4G Clinical, Ms. Araujo was the President and owner of Ojuara, LLC, an independent consulting firm servicing the health care and pharmaceutical industries, as well as technology development companies.
Kelly Stanton, Director of Quality, Qualio
Kelly brings over 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems and is an advisor to over 30 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape. She leads a team of talented industry-experienced quality professionals who work wiDevon Campbellth companies in regulated industries on a daily basis.
Devon Campbell, Founder, Prodct LLC
Devon thrives at the intersection of engineering, biology, and design while leading the development of innovative, commercially successful medical devices, IVDs, and companion diagnostics. In addition to his advisory firm, Prodct LLC, Devon is committed to giving back to the medtech and biotech start-up community as a mentor through MassChallenge, an expert for the NIH RADx program, and a frequent podcast and conference speaker. He is also on the executive teams, Boards of Directors, and Advisory Boards for several start-ups. Prodct is a boutique advisory firm focused exclusively on supporting emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies through bespoke strategy development, infrastructure creation, and sleeves-rolled-up execution support. Prior to starting Prodct, Devon matured over several decades into a seasoned product development expert in the field of medical devices and life science tools having developed, launched, and commercialized many highly successful regulated devices. He’s similarly helped build successful teams and organizations, including two with high-value exits; a $3.4B acquisition in 2008 and $74M IPO in 2017.
Christie Johnson, Founder, Kasota Engineering LLC (recently joined Prodct)
Christie is a Mechanical Engineer with deep experience at the crossroads of product development and quality. She started her career working in the aerospace industry before migrating into medical devices. After several years working at world-class organizations, she struck out on her own, founding Kasota Engineering, LLC in 2016 to help startups and very small firms establish quality systems, design history files, and (her favorite!) risk management files. Christie enthusiastically supports and advocates for program success and often builds long-term, multi-faceted relationships encompassing both engineering/technical and quality system maturation roles. Most recently, Christie joined forces with Devon Campbell at Prodct and together they provide uniquely tailored strategy, advice, and implementation support to early stage medical device and medtech firms.
Who Should Attend?
Anyone involved in quality management and/or regulatory compliance, including new start-up founders and executives:
- Quality Management
- Quality Assurance
- Regulatory Affairs
- Clinical Operations
- Product Managers
- Senior Managers
- Clinical Research Staff
What You Will Learn
In this webinar, participants will learn about:
- How to define a quality culture at your organization
- A roadmap to instilling quality as a core value of your company
- How to drive awareness and buy-in from leadership and team members
- Case study of quality culture with 4G Clinical
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.