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  • 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance
    5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)
    5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  • 7 Steps To Navigate Six Sigma’s “Improve” Phase
    7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

More From Pharma Contributing Editors

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5 Key Takeaways From The FDA's Revised Quality Metrics Guidance 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1) 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

7 Steps To Navigate Six Sigma’s “Improve” Phase 7 Steps To Navigate Six Sigma’s “Improve” Phase

In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

More From Pharma Contributing Editors

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TITLE SUMMARY DISPLAY

  • 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  • 7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

5 Key Takeaways From The FDA's Revised Quality Metrics Guidance 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1) 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

7 Steps To Navigate Six Sigma’s “Improve” Phase 7 Steps To Navigate Six Sigma’s “Improve” Phase

In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

More From Pharma Contributing Editors