Showing items tagged as Audit Management

  • Five Common Issues that could Jeopardize Training Compliance

    9 December, 2014 Cindy Fazzi, Staff Writer

    If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.

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  • American Laboratories Begins Phase II of MasterControl

    12 November, 2014 MasterControl

    American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

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  • On the Quality of Vendor/Supplier Audit Responses

    8 April, 2014 by John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants; Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.

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  • Changing Supplier Controls Requirements

    26 March, 2014 by John E. Lincoln, J.E. Lincoln and Associates

    Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.

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  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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  • What to Expect When They're Inspecting - Part II

    10 April, 2012 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • What to Expect When They're Inspecting - Part 1

    18 October, 2011 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

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  • What Does 'Readily Available' Mean?

    7 November, 2010 MasterControl

    If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.

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