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GxP Lifeline
  • 2021-bl-fda-warning_132x132

    Prelude to an FDA Warning Letter

    Receiving a warning letter involves action items and additional correspondence with the U.S. Food and Drug Administration (FDA). All of which delays your company in getting product out the door. Learn some of the common reasons life sciences companies receive FDA warning letters, so you can avoid making the same mistakes.

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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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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  • 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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  • 2019-bl-thumb-going-green-packaging-nutraceuticals-trends

    Top 5 Nutraceutical Trends: Going Green With Packaging

    Plastic is the new GMO. It’s experiencing similar ostracization due to the large amounts of plastic produced each year that winds up in landfills and in the ocean. Moving away from a plastic dependency requires nutraceutical companies to be prepared with innovative ideas and a manufacturing process that is easily adaptable.

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  • 2019-bl-thumb-using-sherlock-holmes-to-pick-a-consultant

    Using Sherlock Holmes to Pick a Consultant

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Building a Vendor Qualification Program for FDA-Regulated Industries

    A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.

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  • 2020-bl-connectivity-02_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • 2020-bl-connectivity-03_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 1

    The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.

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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-how-minimize-protocol-deviations

    How to Minimize Protocol Deviations

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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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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  • human-robot-ai-technology-132

    EU Policy 70 and Redaction — PleaseReview’s Take on It

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • Med Device: How to Address the Documentation Burden of Design Control

    Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

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  • 7 Steps to Respond to an FDA 483 Inspection Observation

    Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.

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  • How Can You Measure the Return on Your QMS Investment?

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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