Trends Report 2022: Findings, Challenges and Plans for a Quality Management System for Life Sciences

Manual quality management methods continue to dominate to a surprising degree. The Global Quality Management Survey found that 38 percent of respondents stated that they still rely entirely on paper and spreadsheets to manage their quality management system. Half still use adapted legacy tools, including shared online folders such as SharePoint. The quality management system for life sciences, as befitting the highly regulated nature of the industry, is generally being supported and nurtured.

But there’s still some way to go before quality professionals are fully happy, resourced and empowered.

Join this webinar for an in-depth discussion regarding the insights that have been discovered from the Global Quality Management Survey. This survey was shared to access global knowledge regarding the state of the industry in 2022 and beyond.

Learning Objectives:

• Discuss how to improve access to resources, quality improvement time and unlock the full potential of quality teams
• Review key challenges that are facing the industry in 2022
• Understand the position of quality on the corporate agenda, in the suitability of their policies and procedures and in the ability of senior leadership to communicate the value of quality internally
• Gain clarity on the myths and realities surrounding a quality management system for life sciences
• Review how implementing actionable strategies for strengthening an organizational foundation can improve in the future growth of the industry

Speakers

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.

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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 with companies in regulated industries on a daily basis.

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Jeanmarie Donovan, Owner, Jeanmarie Donovan Consulting LLC

Jeanmarie Donovan has 20 years of professional experience in CMC and Quality Assurance. Currently, she is owner of Jeanmarie Donovan Consulting, LLC, a company that specializes in supporting the development of pre- and post-marketed compounds by consulting on projects in quality assurance and regulatory strategy. Previously, she was responsible for site selection and management of CMOs for Genentech. Prior to her work at Genentech, Jeanmarie was an Associate Director of CMC at Biotie Therapies, and she has held multiple positions previous to that in start-up companies. She holds a B.S. in Biochemistry from San Francisco State University and a M.Sc. in Strategy and Leadership (Sloan Fellow) from London Business School.

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Greg Norton, Quality Manager, KSE Scientific

Greg Norton is a quality manager at KSE Scientific, a bioprocess manufacturer located in Durham, North Carolina specializing in the production of sterile products for tissue banking, pharmaceutical, and biotech industries. Greg has 20 years experience in various quality management roles overseeing all facets of the medical device supply chain. He has an MBA from Wilkes University and is a certified Senior Professional in Supply Management (SPSM).

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