• Do you know how to navigate the FDA's website

    12 July, 2011 MasterControl

    by Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

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  • eCTD Specification Document (Version 3.2) Provides Recommendations - Did You Know?

    14 April, 2017 MasterControl

    File names should only use lower case characters and hyphens and should have only one file extension that indicates the format of the file.  You should avoid using what are known as “special characters” in your file names such as punctuation, underscore, spaces, or other nonalphanumeric symbols.  The only exception to this is regarding SAS transport files to the FDA, in which they will allow underscores.  Internal corporate naming conventions that include date or

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  • For Medical Device Companies - Did You Know?

    MasterControl

    Inspections of medical device facilities have already started to rise as funds set aside for the FDA have increased under the Obama administration. The need for these inspections, according to a recent article1 from FDANews, has led the agency to hire 450 inspectors to address device inspections as well as those inspections required within the drug and food industries. The article also refers to the new inspectors' large range of varied experience, touting them as "recent college graduates, indu

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  • ISO Committees Are Available for Consultation - Did You Know?

    MasterControl

    An online article1 published on the ISO.org website makes it clear that companies that are seeking to become ISO certified can receive assistance regarding "horizontal" topics. This consultative assistance can be helpful for a wide range of companies participating in a variety of vertical markets.

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  • Adhering to ISO Standards - Did You Know?

    MasterControl

    It's no secret that adhering to ISO standards can help companies save money when economic times get tough but what is it about ISO standards that really makes the difference? Less waste? More consistent progress? Less time spent on quality administration? Or is it simply the confidence that ISO standards instill in employees by making processes and systems understandable at a deeper level?

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  • More Than One Way to Kill CAPA - Did You Know?

    MasterControl

    A new approach to QMS and CAPA management isn't necessarily a revolutionized approach from the one your company already employs. Ken Peterson, CAPA expert and founder of Pathwise, Inc., states that "Making a few well-timed changes to build more intelligence into your process by having key questions prompt you from data point to data point can make it easier for those doing the work, as well as for those who need to see the logic."

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  • Life Science Manufacturers Analyzed in Aberdeen Report - Did You Know?

    the AberdeenGroup could not be categorized as Best-in-Class manufacturers?

    According to a recent AberdeenGroup report, life science companies face pressures that "typical" manufacturers do not. These pressures include "complying with government regulation and providing traceability in their operations." Because of these pressures, life science companies often stand at a mediocre level in terms of first pass yields, overall yields, and DPMOs (defects per million opportunities).

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  • Medical Device Companies Required to Submit MDRs Electronically - Did You Know?

    MasterControl

    When the pending FDA rule is finalized it will require more than 56,000 medical device importers, manufacturers and other medical device facilities/professionals to submit medical device reports (MDRs) in an electronic format (otherwise known as electronic medical device reports (eMDRs)). eMDRs have been an option for medical device companies for a few years but this ruling—once finalized—will result in very significant changes that will be required by law for all medical device comp

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  • Medical Device Companies Avoiding FDA Inspections? - Did You Know?

    MasterControl

    Sounds like a dream come true! Did you know that some medical device companies may be able to "avoid" FDA inspections?

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  • Medical Device Tax Means a 30% Spike

    MasterControl

    Did you know that if the 2.3% medical device excise tax fails repeal, the industry will need about $2.5 billion to comply with the next tax levy?

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  • Mergers in Pharma Industry Diminish Productivity - Did You Know?

    MasterControl

    Recent studies indicate that mergers in the Pharmaceutical Industry significantly diminish productivity levels, especially in R&D. As with any merger, management and employees are plagued with personal uncertainty, but more importantly, with an inability to make swift decisions pertaining to joining pipelines, consolidating vendors and physical assets. During mergers, R&D talent also tends to slow down the combined entity, not to mention innovation as a whole.

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  • New FDA Guidelines for Informal Medical Device Application Review - Did You Know?

    14 April, 2017 MasterControl

    Since more resolute performance goals have been set forth by the agency after the 2007 FDA Amendment Act, increased interaction during the review process between the FDA and life science industries has become an issue of note. According to the guidance, interactive reviews will facilitate increased informal interaction between the FDA and applicants and enable the exchange of vital scientific and regulatory information. To view the guidance, follow the link below.

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  • Device Makers Can Use New FDA Database

    7 November, 2010 MasterControl

    There is one thing that every device manufacturer knows: it can be very difficult to effectively manage and support suppliers.

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  • New FDA Report Reveals Barriers to Medical Device Quality

    7 December, 2011 MasterControl

    You may know that the volume of adverse reporting is on the rise. Did you know that recalls have risen slower than adverse events but have matched industry growth? And that in general, critical, life-sustaining devices are responsible for a growing share of adverse event reports, but not of recalls?

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  • Supplier Audits in Pharmaceutical Environments - Did You Know?

    5 September, 2017 MasterControl

    What is it that pharmaceutical manufacturers should do every 12-18 months? According to a recent FDANews update, pharmaceutical manufacturers should "conduct audits every 12 to 18 months for suppliers of critical materials," "perform a risk analysis to identify areas of concern for monitoring," and "negotiate quality agreements before signing a contract with a new supplier."

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  • The Effects On Biological Products From Severe Weather - Did You Know?

    MasterControl

    The tornadoes and hurricanes that accompany summer often bring unexpected changes to life science workplaces. Seasonal power failures and floods can play havoc with biological products under study or in production in laboratories and other facilities.

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  • Until April 2011, the FDA is taking comments regarding the recently issued PGx Draft Guidance

    8 March, 2010 MasterControl

    Until April 19, 2011 FDA is taking comments regarding the recently issued PGx Draft Guidance. The guidance documentation was written to provide recommendations to drug manufacturers regarding how genomic information can be used during the drug development process. According to GenomeWeb News the draft's primary purpose is "...helping drug developers evaluate how human genomic variations can affect the way drugs function in different people and how they can cause varying clinical responses."1 Als

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  • Document Review Process Can Reduce Document Review Cycles

    13 April, 2017 MasterControl

    Studies undertaken by PleaseTech's PleaseReview™ customers show that using collaborative document review can reduce document review cycles by as much as 65 percent. Take for example a 45-page document that has a document review cycle of 14 days. This 14-day period is made up of two seven-day periods. The first seven-day period consists of a five-day initial review followed by a two-day author consolidation. This period is followed by a second seven-day period (post comment consolidation) t

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  • Technology Shift in Pharmaceutical Industry - Did You Know?

    MasterControl

    eCTDs for example are subject to change, and their continuous evolutions are promoting discussion in areas and initiatives such as RPS (Regulatory Product Submission). Companies focusing their efforts on "eCTD Tools" however may well find that they will need to re-invest - or possibly make drastic changes - every time a new standard is announced. This has already been witnessed with the move from the eNDA to the eCTD with the FDA - spurring new systems, new validation, new training and natural

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  • Refusal to Accept Your Durg or Biologic Submission - Did You Know?

    MasterControl

    The eCTD format significantly cuts the cost and time of handling paper submissions, which can be equivalent to a semi-tractor full of paper, for regulatory authorities. It is the preferred format for regulatory reviewers in agencies in Europe, North America, and Asia. However, the eCTD format requires that the content be provided in fully-navigable Adobe Portable Document File (PDF) format to facilitate reviewer access to the content. This means that the document must have a hyperlinked table

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