Showing items tagged as FDA

  • 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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  • 2020-bl-thumb-design-control-process_132x132

    What Verification and Validation Activities are Required for a First in Human Study?

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • 2017-bl-fda-finalizes-guidance-page-image

    FDA 21 CFR Part 11 and Predicate Rules: What You Need to Know

    Through FDA 21 CRF Part 11, the U.S. Food and Drug Administration (FDA), established that electronic records and signatures are as valid as paper records and handwritten signatures. Maintaining compliance is dependent on your understanding of the FDA predicate rules that apply to your company.

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  • 2020-bl-thumb-covid-19-and-fdas-response

    Weighing FDA's Response to the COVID-19 Pandemic

    The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.

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  • 2020-bl-humb-fda-trending-toward-cloud-technology

    FDA Trending Toward Cloud Technology to Drive Innovation

    The life sciences industry is experiencing a surge of scientific and technology advances. However, there remains a sizeable gap between the discoveries and the technologies needed to translate them into useful therapies. Recently, the U.S. Food and Drug Administration (FDA) introduced a Technology Modernization Action Plan (TMAP) to foster modernization in the life sciences industry in order to more efficiently expedite scientific innovation.

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  • 2020-bl-thumb-working-together-to-beat-covid-19

    Working Together to Beat COVID-19

    At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.

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  • 2019-bl-thumb-the-surge-of-manufacturing-data-integrity-violations

    Surge of Data Integrity Violations Irritating the FDA

    Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.

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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    2019 Med Device Trends to Watch For: Regulatory Changes

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • 2018-bl-thumb-modernizing

    Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

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  • Compliance Pathways to Medical Device Manufacturing

    De Novo Becoming Faster and Easier Pathway to Market

    There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

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