Showing items tagged as Corrective action and preventative action (CAPA)

  • 5 Common Compliance Problems and How to Avoid Them

    February 25, 2021 By Regina Fullin, Vice President of Regulatory Affairs and Quality Assurance Consulting, Compliance Team, LLC

    Five of the most common compliance problems and how to avoid them including documentation issues, lack of quality oversight, neglecting to assess risks, not learning from mistakes, and failure to follow through on commitments.

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  • Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

    February 15, 2021 By Christine Park, Founder and Consultant, Christine Park & Associates

    The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.

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  • Trend Analysis: Making the Most of Meaningful Quality Data

    November 13, 2020 By James Jardine, Staff Writer

    Trend analysis in quality management is particularly useful for monitoring process changes that can yield substantial process improvements. Learn how advanced digital tools can supercharge your trend analysis capabilities by providing access to real-time, connected quality data.

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  • A Look at Reducing Human Error on the Manufacturing Floor

    October 13, 2020 By Dr. Ginette Collazo, CEO, Human Error Solutions

    CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.

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  • Using Connected Quality to Track Down Problems

    October 7, 2020 By Sarah Beale

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • Deviation and Change Control in Pharmaceutical Manufacturing

    September 10, 2020 by David Butcher, Staff Writer

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    July 27, 2020 by Sarah Beale, Staff Writer, MasterControl

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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  • 5 Helpful Quality Event Management Tips From a CAPA Pro

    July 22, 2020 By James Jardine, Staff Writer, MasterControl

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

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  • 7 Steps to Ensure CAPA Success

    January 9, 2020 by Mike Rigert, Staff Writer, MasterControl

    Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action preventative action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.

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  • Expert Tips on Enhancing CAPA Through Innovation

    October 2, 2018 by James Jardine, Staff Writer, MasterControl

    This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    May 24, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    May 22, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • Proving the Effectiveness of Mock FDA Audits

    May 10, 2018 by Patricia Santos-Serrao, Director of Product Strategy, MasterControl

    A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

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  • Quality Problems: Beyond Root Causes to 'Real Causes'

    May 8, 2018 by David Manalan, Principal, INQC Consulting

    Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    April 19, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Holiday Party Hosting Tip: Get an eQMS

    December 14, 2017 by David Jensen, Staff Writer, MasterControl

    It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event—not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).

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  • Quality 4.0: Harnessing Technology to Enhance Traditional Quality Methods

    November 21, 2017 by Mike Rigert, Content Marketing Specialist, MasterControl

    Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.

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  • Revisiting CAPA for a More Modern (and Effective) Approach

    October 17, 2017 by Peter Knauer, Managing Partner, Sage BioPartners

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • ISO, Regulatory Requirement Changes Loom

    September 1, 2017 B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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

    August 22, 2017 by James Jardine, Staff Writer, MasterControl

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

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