• You Can Stop Wondering - Did You Know?

    MasterControl

    It's common for blood and/or biologics companies to struggle with the continuous task of training management. Even if a company has access to a team of highly trained personnel with the express duties of managing training (a company usually doesn't have access to this) training management is still a daunting task.

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  • FDA Taking Comments Regarding PGx Guidance Document

    12 April, 2011 MasterControl

    This article was originally published by EduQuest in the March 2011 issue of EduQuest-ions & Answers.

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  • What Happens to eCTD Submissions - Did You Know?

    MasterControl

    When your eCTD arrives at the correct document room either on CD-ROM or into the Electronic Submission Gateway (ESG), the FDA will conduct a technical validation check on the submission to ensure that it can be opened, processed, and archived. In March of this year, the FDA issued the validation criteria to be used for their validation processes. Specifications for eCTD Validation Criteria version 1.0 outlines the items that will be checked in the eCTD and grades errors found by severity. If

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  • Electronic Submissions Must Be in eCTD Format - Did You Know?

    14 April, 2017 MasterControl

    The eCTD delivery mechanism streamlines the submission process by insuring that only the most up-to-date documentation is submitted. FDA will still allow hard-copy paper submissions but after December 31, 2007 other electronic formats (such as eIND, eNDA or hybrid eCTD/eNDAs) will no longer be accepted. All regulated organizations intending to send submissions electronically are urged to contact the FDA prior to preparing submissions using the eCTD specifications. Start a dialogue with the FDA a

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  • SAS Datasets in Version 5 - Did You Know?

    MasterControl

    Compliance with FDA’s eCTD requirements need not be a burden for any size company when “renting” a solution is just as effective as making the investment to buy a solution.

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  • 21 CFR Part 11 Requires Signatures - Did You Know?

    MasterControl

    That 21 CFR Part 11 requires electronic signatures to be linked to their respective electronic records?

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  • The Help of Filtering Technology - Did You Know?

    MasterControl

    That you can give individual business units within your enterprise-wide system the flexibility to optimize their local processes with the help of filtering technology?

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  • EU in Process of Establishing Biobank - Did You Know?

    MasterControl

    The Pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) are in the process of creating the first European Union Research Infrastructure Consortium.

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  • EU Will Use Electronic Solutions - Did You Know?

    MasterControl

    According to an article by José Manuel Barroso and Günter Verheugen (President and Vice President, respectively, of the European Commission), the commission's ongoing campaign "to cut the regulatory red tape" will use electronic solutions to boost international trade, saving European businesses 2.5 billion per year when fully operational.

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  • Revision of EU Medical Device Directives - Did You Know?

    MasterControl

    There was frantic activity in Europe during May 2008 following the publication of a discussion document on the recast of the Medical Devices Directives that sparked a hot debate on the future of medical regulation in Europe. The recast did not reject the new approach but the European Commission are concerned--amongst many other items--about the consistency of notified body performance, market surveillance, and vigilance; however, these were also issues raised in the Revision of the Active Impla

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  • FDA 483s Related to CAPA Issues - Did You Know?

    MasterControl

    Did you also know that your CAPA system relies almost entirely--at least initially--on the effective management of events such as nonconformances and deviations?

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  • FDA Allows Sponsors to Test eCTD Understanding - Did You Know?

    MasterControl

    The FDA Pilot program, created in 2005, was designed to allow sponsors to demonstrate their understanding of the eCTD and their ability to create a technically valid sample submission. The sample submission should be representative of the final eCTD dossier and should, at minimum, include navigational items for all modules. When compiling the Module 4 and 5 Study Report, the sponsor should also demonstrate their understanding of the study data specifications, e.g. study tagging files. Once submi

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  • FDA is Pursuing an Electronic Future - Did You Know?

    MasterControl

    The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).

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  • FDA Inspection Bound to Increase - Did You Know?

    MasterControl

    According to a recent article1, the FDA is taking inspections in countries outside the U.S. more seriously than ever before. So seriously in fact that overseas inspections are likely to rise by as much as 50 percent.

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  • Related to CAPA Requirements - Did You Know?

    MasterControl

    That under key FDA regulations, requirements pertaining to nonconformance disposition are directly related to CAPA requirements?

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  • Medication Safe Use Initiative - Did You Know?

    MasterControl

    The Food and Drug Administration (FDA) launched its Safe Use Initiative in November 2009 to take a more proactive role in reducing the risk of patients suffering unnecessary injuries due to medication use. Following an in-depth analysis of both unavoidable and manageable medication risks, the agency concluded that steps needed to be taken to establish a formal, coordinated system to protect the public from preventable harm caused by medication use. FDA's report, FDA's Safe Use Initiative: Collab

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  • FDA Proposing Amendment to 21 CFR Part 803 - Did You Know?

    MasterControl

    The proposal—whether it will soon be implemented or not—has manifested the obvious drive FDA has toward automated systems. For example, once FDA is fully automated industry will have two options for electronic submission of MDRs including one for low volume reporting and another for its high volume counterpart. Industry will also benefit by "doing business" with an agency that will be far more efficient in terms of data collection, response, feedback and analysis. Those benefits alon

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  • Developing FDA and International Regulatory Strategies - Did You Know?

    MasterControl

    Too often, medical device innovators develop their regulatory submission strategy near the end of the product development process, rather than at the start. They often make launch date commitments without considering important regulatory submission issues, such as product efficacy claims and testing to support those claims.

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  • FDA Safe Use Initiative - Did You Know?

    MasterControl

    As reported by FDANews, the Safe Use Initiative is an important step toward lowering avoidable medication risks.

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  • FDA's Sentinel System - Did You Know?

    14 April, 2017 MasterControl

    The Food and Drug Administration's (FDA) Sentinel Initiative was launched May 2008 in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA).1 The FDAAA provisions mandated that the FDA take the lead in developing an electronic surveillance system to increase the agency's capacity to monitor regulated medical products on the market. Although the FDA has a number of systems already in place to track adverse events and product problems, these monitoring tools all represent a p

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