FDA

  • Connecting and leveraging data product lifecycle

    Connecting and leveraging data product lifecycle

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  • 2020 Ultimate Guide to Connected Quality Data

    2020 Ultimate Guide to Connected Quality Data

    Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...

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  • Episode 4: ISO vs. cGMP vs. FDA Requirements.

    Episode 4: ISO vs. cGMP vs. FDA Requirements.

    In Episode 4 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook discuss FDA requirements and how to comply with them.

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  • Episode 5: FDA Current Guidance and Exemptions15:56

    Episode 5: FDA Current Guidance and Exemptions

    In Episode 5 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook talk specifically about how digitizing helps with the complexity of

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  • FDA Fronts Pivotal Life Sciences Trend in 2020

    FDA Fronts Pivotal Life Sciences Trend in 2020

    This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.

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  • Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments

    Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments

    Learn about the most common 483 observations and audit findings, and avoid warning letters by staying compliant and addressing issues in the stipulated time period.

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  • Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

    Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

    The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and the EMEA Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems.

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  • 21 CFR Part 11 Compliance Checklist

    21 CFR Part 11 Compliance Checklist

    If your company is planning to convert to an automated system for managing documents and processes, make sure the new system meets the needs outlined in this 21 CFR Part 11 Compliance Checklist.

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  • The FDA Just Called - Now What0:00

    The FDA Just Called - Now What

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  • Completing an FDA Inspection With MasterControl1:20

    Completing an FDA Inspection With MasterControl

    MasterControl customer Contract Pharmacal Corporation used to be a paper-based organization. They’ve greatly benefited from switching to MasterControl’s electronic quality management system (QMS).

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  • The FDA Just Called - Now What0:00

    The FDA Just Called - Now What

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  • FDA/ISO Compliance Toolkit

    FDA/ISO Compliance Toolkit

    Medical device managers are complying with FDA requirements and better aligning with evolving industry trends by recognizing the value of moving to a digital quality management system.

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  • Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

    Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

    The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.

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  • FDA Inspections of Clinical Investigators: Are You Ready?

    FDA Inspections of Clinical Investigators: Are You Ready?

    In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials.

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  • Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

    Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

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  • 11 Free Resources to Boost Your Medical Device FDA Readiness

    11 Free Resources to Boost Your Medical Device FDA Readiness

    This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality-related processes.

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  • How to Successfully Complete an FDA Inspection

    How to Successfully Complete an FDA Inspection

    This white paper provides an overview of the inspection process, describing the preparation for an inspection, what will happen during an inspection, and what to expect after an inspection occurs.

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  • The Value of Studying and Utilizing FDA's QSIT Manual

    The Value of Studying and Utilizing FDA's QSIT Manual

    The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.

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  • MasterControl eMDR™

    MasterControl eMDR™

    The FDA requires medical device manufacturers to report any adverse events to the agency.

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  • Working on a Post-Inspection FDA Response - MasterControl51:38

    Working on a Post-Inspection FDA Response - MasterControl

    After an FDA investigator has inspected your facility and issued a Form 483, it is critical to meet the post-inspection response requirements. Failure to do so can have devastating consequences.

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