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

  • Pharma manufacturing professional following CAPA best practice.

    5 CAPA Best Practices for Life Sciences Manufacturers

    Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.

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  • 2021-bl-steps-to-capa-success_132x132

    7 CAPA Process Steps to Ensure CAPA Success

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

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  • 2021-bl-systems-used-clinical-trials_132x132

    5 Things to Know When Using Computerized Systems in Clinical Trials

    Innovative streamlining technologies like the cloud are transforming the way clinical trials are conducted and monitored. If you want to stay in the FDA’s good graces, there are five key elements you need to understand when using digital tools in your clinical activities.

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  • 2021-bl-capa-documentation_132x132

    Five Steps to Simplifying CAPA Documentation Processes

    CAPA documentation failures are the most common citation in Form 483s that the FDA issues to medical device manufacturers. Learn five prudent measures you can take to ensure your CAPA documentation meets regulators’ expectations.

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  • 2021-bl-10-questions-iso-13485_132x132

    Your Top 10 Questions About ISO 13485:2016—Answered!

    Five years ago, the International Organization for Standardization (ISO) published the ISO 13485:2016 standard. This post addresses the most common questions industry stakeholders have asked about the standard and its current status.

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  • 2020-bl-quality-excellence-03_132x132

    Solving Quality Issues and Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

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  • 2020-bl-quality-excellence-02_132x132

    5 Critical Factors in the SMART CAPA Process

    Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.

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  • 2021-bl-5-compliance-mistakes_132x132

    5 Common Compliance Problems and How to Avoid Them

    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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  • 2021-bl-effective-failure-investigation_132x132

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

    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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  • 2020-bl-reducing-human-error_132x132

    How to Reduce Human Error on the Pharmaceutical Manufacturing Floor

    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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  • 2020-bl-using-connected-quality_132x132

    Using Connected Quality to Track Down Problems

    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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  • 2020-bl-change-pharma-mfg_thumb

    Deviation and Change Control in Pharmaceutical Manufacturing

    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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  • city-technology-nightscape-132

    Avoiding a Time Traveler’s Mindset With CAPA Effectiveness Checks

    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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  • 2018-bl-thumb-fdas-top-10-drug-gmp-inspection-citations-2017

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

    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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  • 2018-bl-thumb-proving-effectiveness-mock-audits

    Proving the Effectiveness of Mock FDA Audits

    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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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    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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  • 2017-bl-revisiting-capa-more-modern-approach-page-image

    Revisiting your Quality CAPA System for a More Modern (and Effective) Approach

    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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  • CAPA in the Food Industry: 10 Tips to Avoid Pitfalls from an Industry Quality Expert

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

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  • gxp-default

    Death by CAPA: Essential Elements of Effective CAPA Systems

    The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

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