Showing items tagged as FDA

  • 483s

    How to Avoid Pharma’s Top 5 FDA Form 483 Triggers

    Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.

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  • 2021-bl-automating-document-control2_132x132

    Why Automation Is Essential for Document Control Compliance

    Global regulatory agencies continue to evolve their processes and technologies to help companies achieve compliance with this critical aspect of quality management. This post explores document control automation practices as well as the efforts of global regulatory agencies to encourage modernization among life sciences companies.

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  • 2021-bl-drug-accountability-clinical-trials_132x132

    Ensuring Drug Accountability in Clinical Trials

    Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    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.

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  • 2021-bl-matt-lowe_132x132

    How to Not Fail an Inspection

    When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.

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  • 2020-bl-manufacturing-excellence-02_132x132

    Test Method Validation, Measurement Systems, and Gauge R&R

    To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation.

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  • 2021-bl-fda-483-observation_132x132

    Top Reasons for Med Device Form 483s and Warnings

    Maintaining compliance in medical device manufacturing is colossal and complex. Any number of things can slip through the cracks and fall into the lap of a regulatory inspector. MasterControl’s industry brief “Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments” helps companies identify and mitigate issues before they lead to extra work and costly delays.

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  • 2020-bl-quality-excellence-03_132x132

    Solving Quality Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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  • 2021-bl-fda-cosmetic-act_132x132

    Life Before Consumer Protection and the Food, Drug, and Cosmetic Act

    Before the Food, Drug, and Cosmetic Act of 1938, shopping could be hazardous to your health. The market was flooded with deceptive and dangerous products. The confidence we have today in food, drugs, medical devices, and cosmetics is largely due to the FD&C Act and the amendments that followed.

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  • 2021-bl-fda-eu-inspections_132x132

    FDA vs. EU Inspections: Similarities and Differences

    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.

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  • 2020-bl-asca-final-guidance_132x132

    The FDA Publishes Three-Part Final Guidance on ASCA Pilot Program

    In Sept. 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies and testing laboratories. The FDA released its final guidance in Sept. 2020. This article highlights key aspects of the updated guidance.

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  • 2021-bl-fda-called_132x132

    The FDA Just Called! Are You Ready for an Inspection?

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual? FDA audits can be stressful, and failing one can have significant consequences. With proper preparation, however, the call to schedule an FDA inspection doesn’t have to be so unnerving.

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  • 2020-bl-nonconformance-management_132x132

    Effective Nonconformance Management Key to FDA and ISO Compliance

    It’s impossible to avoid occasional nonconforming products and materials. But what’s most important for manufacturers of regulated products is how nonconformances are managed. Learn how to handle nonconformance challenges, avoid warning letters and maintain alignment with FDA and ISO requirements.

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  • 2020-bl-rca-virtual-audits_132x132

    Adjusting to the FDA’s new hybrid Audit and Inspection Model

    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.

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  • 2020-bl-501k-guidance_132x132

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

    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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  • 2020-bl-gcp-compliance-hack_132x132

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

    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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  • 2020-bl-prepare-dhf-fda_132x132

    Is Your Design History File Prepared for an FDA Inspection?

    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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  • 2019-bl-thumb-purpose-bulit-manufacturing-systems

    Understanding GxP Predicate Rules Is Key to Compliance With FDA 21 CFR Part 11

    FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.

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  • 2020-bl-fda-guidance_132x132

    FDA Sets Out to Curb Data Integrity Violations With Guidance on Data Handling

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.

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  • 2020-bl-thumb-quality-culture-data-integrity_132x132

    Having a Good Quality Culture Improves Your Data Integrity

    Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.

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