• FDA 21 CFR Part 11 And Predicate Rules Article

    14 April, 2017 David Ade

    Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

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  • Final FDA Rule on Dietary Supplements (21 CFR Part 111) Guidance

    14 April, 2017 Sharon Phillips

    In June 2007, the U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.

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  • Making the Transition to an E-System

    14 April, 2017 Janet Gough, Course Director, Center for Professional Innovation and Education

    This is the first part of a two part article.

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  • New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

    14 April, 2017 Robyn Barnes

    HHS Secretary Mike Leavitt recently announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

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  • Life Science Executives Facing Jail Time?

    14 April, 2017 Marci Crane

    As corporate corruption--with or without executive intent--increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures. The FDA's increased powers include the following:

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  • The Hot Potato of Responsibility - How to Manage Outsourcing and Not Get Burned

    14 April, 2017 Martin Browning, President, EduQuest, Inc., and former FDA Investigator/Special Assistant to the Commissioner of Regulatory Affairs

    Everything can be outsourced - except responsibility. That's a rule the U.S. FDA lives by, and one you should embed in your policies, SOPs, and corporate culture.

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  • Optimizing Your eCTD Submission: How to Achieve an Efficient and Timely Review - GxP Lifeline

    14 April, 2017 MasterControl

    Ginny Ventura of the FDA?s Review Technology Staff shares the top 12 mistakes in eCTD submissions she sees nearly every day

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  • Do's and Don'ts in Process Mapping for Life Science Companies

    14 April, 2017 John Gagliari

    The medical device and pharmaceutical industries are built upon process orientation to complete tasks in a uniform and documented fashion. Both industries also depend upon a systematic series of linked and reproducible activities completed by trained people to enable inputs to become outputs and outputs to realize a return on investment.So, how does process mapping help these industries in turning inputs into predictable outputs that would help them comply with regulations, as well as realize co

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  • Project Management in a Learning Organization: Thriving on Change While Delivering Results

    14 April, 2017 MasterControl

    Life science industries are no different than any other money-making organization:  their bottom line is profit.  The difference in their profitability, though, often lies in the way they conduct their business.Peter Senge of the Massachusetts Institute of Technology advanced the theory of the learning organization.  He said learning organizations are “…organizations where people continually expand their capacity to create the results they truly desire, where n

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  • Meet a New Alligator, it's the QA/IT Disconnect

    14 April, 2017 Keith Parent

    By Keith Parent

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  • Increased Disclosure of Food, Drug and Med Device - Did You Know?

    14 April, 2017 MasterControl

    Did you know that democratic legislators are vying for the increased disclosure of food, drug and medical device information?

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  • GMP Training Exams - Did You Know?

    14 April, 2017 MasterControl

    In the FDA environment, adequate and continuous personnel training is essential in manufacturing safe, reliable, and high-quality products. Companies are required to implement and document GMP training to make sure that their personnel know how to perform their duties within company and industry guidelines. What better way to prove employee competency than through exams? When the FDA investigator comes, your employees should be able to demonstrate their skill level in their daily work, but exam

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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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  • 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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  • Whats in Your Toolbox? Choosing the Right Tool for Quality Improvement

    14 April, 2017 Bonnie Messinger

    Quality improvement tools are like any other tool set. Each basic tool has a brood of new and improved versions intended for increasingly specialized applications. A seasoned facilitator may have literally hundreds of tools at her disposal. However, finding a few basic favorites and learning them well is sufficient for most applications.

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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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  • 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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  • 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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  • Eliminating 'Rogue' Document Issues - Did You Know?

    13 April, 2017 MasterControl

    Although, certainly, the prospect of securely managing a corporation's "controlled content" is a challenging proposition, especially in today's fast-paced, Internet environment, where electronic documents can be readily copied, distributed, and shared with virtually anyone, there is a solution, one that effectively defies even the most challenging of loopholes.

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  • Pharmaceutical Companies Identify Ways to Improve - Did You Know?

    13 April, 2017 MasterControl

    Single sourcing is a "write once, use many" approach to support the implementation of standard operating procedures (SOPs) and approved work instructions by allowing companies to enter their operating instructions into a single repository in order to automatically generate and update critical training and performance support materials.

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