GxP Lifeline

 

  • 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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  • Compliance Data: A New Solution for Maintaining Cannabis Supply Continuity

    September 17, 2020 By Matt Dell, Acting Head of Marketing, Outspoke

    Cannabis supply chains need to deliver high-quality products with consistency and foresight. Using state compliance data, it’s possible to ensure supply networks and regulators have all the necessary information they need for greater visibility and collaboration.

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  • Change Control — Continuous Quality Improvement in FDA and ISO Environments

    September 16, 2020 By Jason Clegg, Marketing Director

    Besides cutthroat competition, manufacturers in the life sciences deal with strict regulatory and ISO quality requirements. Changes in processes need to be carefully managed to ensure that products stay safe and effective.

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  • Why COVID-19 Is Driving Companies Toward the Cloud

    September 15, 2020 By David Jensen, Staff Writer

    As the COVID-19 pandemic escalated, urgency and adaptability became the theme for organizations as they were suddenly tasked with enabling their entire workforce to work remotely. This scenario has largely been the impetus for more companies accelerating their migration to the cloud.

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  • Deviation and Change Control in Pharmaceutical Manufacturing

    September 10, 2020 by David Butcher, Staff Writer

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • What Connected Quality Means for Training

    September 9, 2020 by Sarah Beale, Staff Writer

    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.

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  • Quality Audit—A Tool for Continuous Improvement and Compliance

    September 4, 2020 By Jason Clegg, Director, Marketing Strategy

    Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.

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  • The Fundamentals of Immunization, Part 2

    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.

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  • The Challenges of Cloud Compliance in a Regulated Environment

    September 2, 2020 by Kevin Grimes, Vice President, Arbour Group LLC

    Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.

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  • The Supplier Audit Learning Curve

    August 31, 2020 By Sarah Beale, Staff Writer

    Supplier audits are the standardized testing of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.

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  • How to Approach Design Control From Both FDA and ISO Viewpoints

    August 28, 2020 by Peter Knauer, Managing Partner and Co-Founder of Sage BioPartners

    Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.

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  • The Fundamentals of Immunization, Part 1

    August 27, 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. Inoculation,vaccination and immunization are terms that are often used interchangeably, but have very different meanings.

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  • Overview of ISO 13485 – Medical Device Quality Management System Requirements

    August 26, 2020 by James Jardine, Staff Writer

    Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.

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  • New Ultimate Guide Presents In-Depth Look at Cloud Technology

    August 25, 2020 by David Jensen, Staff Writer

    Discoveries and new opportunities are expanding across the industrial spectrum. At the same time, more businesses are modernizing their operations to benefit from scientific and technology innovation. The core of all this progress and growth is the cloud.

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  • Top 5 Shop Floor Safety Tips

    August 21, 2020 by James Jardine, Staff Writer, MasterControl

    Optimizing shop floor safety practices is as straightforward as abiding by five fundamental manufacturing safety tips. Learn how the right ideology can enable a manufacturer to establish effective shop floor safety practices and extend a safety-centered mindset across the entire enterprise.

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