December 4, 2020
By James Jardine, Staff Writer, MasterControl
With so many similar sounding terms related to quality in life sciences manufacturing, it’s easy to get confused about their definitions and intersections. Learn the purposes of quality assurance, quality control and quality management, their overlap and the differences between each critical function.
December 3, 2020
By Steve Lynn, Executive VP of Pharmaceuticals
The U.S. Food and Drug Administration is changing their approach to audits. Understand how to prepare for a virtual inspection and how to ensure it goes smoothly.
November 24, 2020
By Beth Pedersen, Staff Writer, MasterControl
Approximately one out of every 10 drug products make it to market. Pharma companies are striving to improve that statistic by implementing more effective quality and risk management measures. Quality by Design (QbD) is one of those measures and it’s becoming more widely adopted by manufacturers in the life sciences industry.
November 18, 2020
By David Butcher, Staff Writer, MasterControl
Additive manufacturing (AM), often referred to as 3D printing, is frequently used for product research and development in many industries and for commercial production in some, including medical device manufacturing. In the medical device industry, it is expected to grow fast, offering significant value in the production of customized, fast-to-market devices.
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.
November 13, 2020
By James Jardine, Staff Writer, MasterControl
Trend analysis in quality management is particularly useful for monitoring process changes that can yield substantial process improvements. Learn how advanced digital tools can supercharge your trend analysis capabilities by providing access to real-time, connected quality data.
November 12, 2020
By Sarah Beale, Staff Writer, MasterControl
For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.
November 12, 2020
By James Jardine, Staff Writer, MasterControl
World Quality Day 2020 provides the ideal opportunity to celebrate quality professionals who go above and beyond. It’s also a good time to have some LOLs about the quality world’s more comical and cringeworthy experiences. Giggle (or groan) along with the entries in the Quality Shorts Film Fest, and find out who won the 2020 Masters of Excellence Awards.
November 10, 2020
By Sarah Beale, Staff Writer, MasterControl
There are multiple things that make Thanksgiving stressful. Relatives and food immediately come to mind. The level of orchestration required to pull off a successful Thanksgiving dinner is ridiculous. While we can’t make it easier to manage a successful Thanksgiving, there are ways to simplify your document management using artificial intelligence (AI) and advanced analytics.
November 10, 2020
By Sarah Beale, Staff Writer, MasterControl
There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.
November 6, 2020
By Christine Park, Founder and Consultant, Christine Park & Associates
A robust, flexible quality management system (QMS) is a critical part of a business. Recent issues with COVID-19 illustrate why it is important than ever to integrate the QMS with the organization’s business continuity plan.
November 5, 2020
By James Jardine, Staff Writer, MasterControl
Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.
November 3, 2020
By David Jensen, Staff Writer, MasterControl
With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.
October 29, 2020
By Homi Dala, Consultant, Brandwood CKC
This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.
October 26, 2020
By David Jensen, Staff Writer, MasterControl
QuVa Pharma is a 503B compounding facility with a large catalog of medicines and a growing customer base. Read how the company has been improving its use of resources, efficiency and quality to keep up with increased production demands and tighter timelines.
October 23, 2020
By David Jensen, Staff Writer, MasterControl
Regulated companies are settling into the reality of COVID-19. New operational paradigms present challenges to hosting audits. See how technology has made it more feasible to conduct various types of audits remotely.
October 21, 2020
By David Butcher, Staff Writer, MasterControl
Legacy technology can be a significant barrier to digital transformation. At Carestream Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms. The company is taking a platform approach to technology modernization, including electronic device history records (eDHRs), to transform manufacturing performance and quality.
