Achieving GxP Compliance For Your Spreadsheets With  An Affordable, Easy-to-Use Excel Plugin
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Achieving GxP Compliance For Your Spreadsheets With An Affordable, Easy-to-Use Excel Plugin

At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.

Investigating Failure For Future Success: Root Cause Analysis
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Investigating Failure For Future Success: Root Cause Analysis

At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.

Performing CMC Activities with an NDA In Mind
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Performing CMC Activities with an NDA In Mind

As oligonucleotide therapeutics development continues to accelerate, there are necessary steps to execute and assure quality of oligonucleotide Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs). The basis of this work begins with “good science” as well as a substantial understanding of the drug development process. Here are the major areas to consider. Clearly Delineate…

When Considering Outsourcing Oligonucleotide Programs, Please, Also Consider Quality.

When Considering Outsourcing Oligonucleotide Programs, Please, Also Consider Quality.

At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.