Many regulated businesses chase a baseline of compliance, setting standard accreditation and audit-passing as the primary objective of their quality teams.
But this approach doesn’t set businesses up for long-term success, or allow them to beat their competitors. As industry bodies from the FDA to the ISPE pivot from a compliance to a quality focus with their new initiatives, businesses need to consider how to treat standard compliance not as an end point, but as a springboard for continuous quality improvement.
This webinar breaks down why quality is the new compliance - and what your business needs to do to harness quality as a long-term competitive weapon.
- Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
- Understand why just complying with industry standards holds your business back
- Learn how to unlock the full potential of your organization and use compliance as a launchpad for an industry-leading quality-centric approach
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.
Black Diamond Regulatory Consulting, LLC
Highly accomplished Science professional with 20 years of experience providing Quality Assurance and Laboratory Management in the Preclinical, Life Science, Nutraceutical and Medical Device market spaces. Demonstrated leadership and proven ability to design, plan and implement projects from conception through completion; able to manage multiple responsibilities without compromise to detail or quality; and maintain an overview of ongoing and evolving projects. Resourceful and analytical problem solver with broad quality, regulatory and safety program management and problem solving skills!
Kelly brings over 20 years of experience in both the pharmaceutical and medical device industry 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 20 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 with companies in regulated industries on a daily basis.