May 8, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
To maintain a competitive edge, companies in the life sciences are increasingly reliant on contract manufacturing partners. From the FDA’s perspective, these partnerships mean that both product owners and their contractors are responsible for cGMP compliance. Learn how CMO quality agreements help both parties uphold compliance.
October 13, 2022
By Ave Love, Staff Writer, MasterControl
Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.
August 16, 2022
By Ave Love, Staff Writer, MasterControl
End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.
March 23, 2022
By Matthew Kanter, Associate Consultant, MWA Consulting, and Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences
With the significant advances in gene and cell therapies, companies producing breakthrough products are facing obstacles ranging from challenges with development to transitioning to commercial manufacturing. Solutions can be found in digital manufacturing execution systems (MES) and quality management systems (QMS).
March 18, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.
November 9, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
July 8, 2021
By David Butcher, Staff Writer, MasterControl
A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.
May 25, 2021
By Sarah Beale, Staff Writer, MasterControl
The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.
May 21, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.
March 12, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.
March 5, 2021
By Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative
In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.
February 17, 2021
By Sarah Beale, Staff Writer, MasterControl
The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.
January 28, 2021
By Cheryl Wagoner, Wagoner Consulting LLC
An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.
December 21, 2020
By David Jensen, Staff Writer, MasterControl
Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.
December 15, 2020
By Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
November 17, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.
October 7, 2020
By Sarah Beale, Staff Writer, MasterControl
Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.
September 3, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.
August 11, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.
