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Showing items tagged as audits

  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

    20 April, 2017 MasterControl

    Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

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  • Site Selection: Don’t Forget About the Study Drug

    13 April, 2017 MasterControl

    As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

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  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

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  • If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

    23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

    The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

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  • Failure of Management with Executive Responsibility

    19 July, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International Inc

    For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS). However, every Chief Jailable Officer (CJO) clearly understands the ramifications associated with not complying with the FDA’s sacred text, the quality system regulation (QSR). In fact, not being able to share at least documented evidence that a management review has occurred (agenda and sign-in sheet) is just not excusable. Heck, the agency even gives a ton of wiggle room with the “planned intervals” requirement, so holding at least one review annually should be a piece of cake. Right? Well, based on the performance of the device establishment targeted in this week’s guidance, the answer is a big “evidently not!” As many of the doctor’s friends and readers know, Dr. D is somewhat of a wisenheimer (look-it-up). However, when it comes entertaining the FDA during one of their friendly visits for a cup of coffee and an inspection, it is always Game On! Enjoy.

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  • What, No Internal Audits?

    21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

    For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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