GxP Lifeline

 

  • Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019

    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.

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  • QuVa Pharma Fosters Agility and Growth by Going Paperless

    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.

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  • Conducting Audits at a Social Distance

    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.

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  • Carestream Health: Modernizing Legacy Technology to Transform Manufacturing and Quality

    October 21, 2020 By David Butcher, Staff Writer

    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Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms.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.

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  • CLIA Certification: 3 Things You Need to Know

    October 20, 2020 By James Jardine, Staff Writer

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

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  • 5 Areas of Focus When Conducting a Supplier Audit

    October 16, 2020 By David Butcher, Staff Writer

    For manufacturers, supplier auditing is essential to gaining visibility into whether a supplier’s products and processes are adhering to a defined quality standard. According to Terrance Holbrook, MasterControl’s director of product, there are five often-overlooked actions that manufacturers can take to improve how they conduct supplier audits.

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  • Aviator Proves the Sky Is Not the Limit for Life-Changing Innovation

    October 15, 2020 by Dave Jensen, Staff Writer

    Read how BraveHeart Wireless Inc. earned 510(k) approval for its Life Sensor Cardiac Monitor within one year.

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  • A Look at Reducing Human Error on the Manufacturing Floor

    October 13, 2020 By Dr. Ginette Collazo, CEO, Human Error Solutions

    CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.

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  • Quality Agreements With Contract Manufacturing Organizations (CMOs)

    October 9, 2020 By James Jardine, Staff Writer

    Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.

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  • Using Connected Quality to Track Down Problems

    October 7, 2020 By Sarah Beale

    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.

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  • FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    October 6, 2020 By David Jensen, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

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  • 3 Challenges that Bill of Materials Software Can Help Resolve

    October 5, 2020 By David Butcher, Staff Writer

    A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.

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  • Happy Manufacturing Day!

    October 2, 2020 by MasterControl

    To celebrate Manufacturing Day, we’re encouraging future manufacturers to look at some of the exciting trends happening in the industry. This includes organizations coming together to address COVID-19 and stepping into the world of artificial intelligence.

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  • An Expert Explains Data Integrity and Organizational Excellence – Part Two

    October 1, 2020 By Dale Thompson, Staff Writer

    Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.

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  • GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger

    September 29, 2020 By James Jardine, Staff Writer

    The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.

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  • Process Verification vs. Process Validation: What You Need to Know

    September 28, 2020 By James Jardine, Staff Writer

    Knowing if a manufacturing process needs to be verified or if it needs to be validated is often a conundrum for medical device makers. Learn the difference between the two compliance-critical activities and circumstances when each is required.

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  • Is Your Design History File Prepared for an FDA Inspection?

    September 25, 2020 By David Butcher, Staff Writer

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

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  • An Expert Explains Data Integrity and Organizational Excellence – Part One

    September 24, 2020 By Dale Thompson, Staff Writer

    Data integrity is closely related to organizational excellence. An expert explains best practices and mistakes to avoid.

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  • What to do When Things Go Sideways (And How to Recover)

    September 23, 2020 By Eric Claude, MPR, Vice President Health & Life Sciences

    When you experience an event such as a product recall or low production rates, resolving these issues can be challenging. Your best bet is to have a road map that helps you get to the root of the problem and recover quickly.

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  • Navigating Life Sciences Manufacturing During a Pandemic

    September 22, 2020 By Sarah Beale

    Life sciences manufacturing during COVID-19 has changed dramatically. That’s why we’ve worked with MedTech Association and MASSMedic to bring you a 10-part webinar series about how to scale and pivot during the pandemic.

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