Webinar Title
Synopsis:
FDA-initiated recalls have increased 115% since 2018, and consumers have taken note. Recent surveys show that nearly half of Americans do not have confidence in the manufacturing process and quality of their medications. And over half wouldn't purchase a product that was previously recalled. This negative consumer sentiment presents an uphill battle for life sciences manufacturers who don't have the right solutions in place. Join us to learn more about the common issues that can lead to a recall and how MasterControl's connected quality management system (QMS) and electronic batch record (EBR) solution can help you prevent them and instil consumer confidence.
Key takeaways:
Why attend? Learn firsthand:
- How avoidable compliance issues can permanently erode patient trust.
- How digitalisation of your current paper processes can help prevent an FDA Form 483.
- How connecting your systems can close gaps in your processes and reduce errors.
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Speakers
Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now will continue his tenure as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl's products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.
Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year post-market clinical study for orthopaedic devices.
Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University
Dallas Volk has two decades of experience in life science manufacturing and quality systems, helping quality organizations to identify, implement and validate technology solutions that have enabled them to achieve their compliance initiatives. As a Solutions Consultant at MasterControl, he uses his extensive quality and manufacturing knowledge to give prospects and customers alike accurate demonstrations of MasterControl solutions and how they solve regulatory and compliance challenges while making users system experiences hassle-free.
Prior to joining MasterControl in 2012, Dallas held many different quality roles in the pharmaceutical and aerospace industries, including being a Quality Engineer for a medical device manufacturer and Quality Inspection team member for the Air Force National Guard.