Showing items tagged as Pharma

  • 2021-bl-eu-qualified-person_132x132

    The European Qualified Person - What's It All About?

    According to good manufacturing practice (GMP) guidelines, companies in regulated environments must adhere to regulations that apply to the development of health care products. For medicinal product manufacturers in the European Union (EU), the person responsible for batch certification and the majority of quality processes is the Qualified Person (QP). This article details the duties and responsibilities of the QP and explains why it’s important for U.S.-based companies to understand the QP’s role.

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  • 2021-bl-explain-your-quality_132x132

    How to Explain Your Quality Job to Young Kids in 4 Steps

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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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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  • 2021-bl-six-corporate-oversights_132x132

    The Rise of Risk: How To Meet Pharma Regulators’ Expectations

    Regulators are intensifying focus on risk-based compliance approaches and pharma companies must adapt to the shift. Discover why process digitization provides the surest route to compliant risk management and learn how to prepare for the increasingly risk-based future of regulation.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

    All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.

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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-unlocking-your-data-potential_132x132

    3 Data Access Enhancements That Expedite Drug Development and Approvals

    Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.

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  • 2021-bl-infrastructure-accessibility_132x132

    3 Practical Ways to Improve Infrastructure Agility in Pharma

    If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.

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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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  • 2021-bl-ai-emerging-tech_132x132

    3 Practical Ways to Prepare for Pharma’s AI-Driven Future

    Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.

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  • 2020-bl-risk-based-approach-validation_132x132

    A Risk-Based Approach to Validation

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • 2020-bl-pharma-quality-by-design_132x132

    What Is Pharmaceutical Quality by Design?

    Approximately one out of every 10 drug products make it to market. Pharma companies are striving to improve that statistic by implementing more effective quality and risk management measures. Quality by Design (QbD) is one of those measures and it’s becoming more widely adopted by manufacturers in the life sciences industry.

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  • 2020-bl-thumb-pharma-trends-brief

    The Platform Advantage: Keys to Keeping Up With Pharma’s Top 4 Trends

    Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.

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  • 2020-bl-helpful-quality-event-mgmt-tips_132x132

    5 Helpful Quality Event Management Tips From a CAPA Pro

    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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  • 2020-bl-thumb-supply-chain-automation-and-ml

    4 Steps to Integrate Technology Into Your Pharma Supply Chain

    An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.

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  • 2020-bl-thumb-pharma-trends-brief

    Top 5 Pharmaceutical Manufacturing Trends in 2020

    The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.

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  • 2019-bl-thumb-proposed-ratings-system-measure-drugmakers

    The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

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  • 2019-bl-thumb-no-1-fda-gmp-inspection-citation

    Different Year, Same Results: QA the No. 1 FDA Drug GMP Inspection Lapse for FY2019

    The latest statistics from U.S. Food and Drug Administration drug GMP inspection citations for FY2019 are making the headlines, and the most common cited reason for manufacturer receiving a warning letter is a familiar one. This article looks at how technology and the latest tools available to pharma manufacturers can significantly increase quality and compliance levels and reduce the likelihood of regulatory warnings.

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  • 2019-bl-thumb-ispe-and-mx

    Pharma Companies See Measurable ROI With Digitized Manufacturing

    Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.

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