PDF Edition - Quality Risk Management for Pharmaceuticals

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Drugmakers must have an effective quality system. However, a basic quality system that just covers the GMP requirements is no longer good enough.

This management report will tell how QRM can be applied both proactively and reactively and explore the potential application of QRM during the different phases of the product lifecycle.

Here’s everything you need to know to develop a top-notch new QRM program — one that meets the tough new requirements of the FDA and international regulators. This plain-English primer can help minimize or eliminate risks to your products and, most importantly, to patients. Get set to discover:

  • Basic principles of QRM and how they are connected

  • Potential applications of QRM and benefits to be derived from them

  • How to embed QRM in a pharmaceutical quality management system

  • During which phases of the product life cycle to apply QRM

  • Pluses and minuses of integrated QRM

  • Pluses and minuses of individual QRM methods and tools

  • How to structure an efficient QRM process — steps to take

  • Risk identification, analysis and evaluation — what to take into account

  • The meaning of risk control, communication, reduction and acceptance

  • What can be learned from the QRM process

  • What information to share during the QRM process, when, and with whom

  • Why to schedule risk review at the end of a QRM process

  • Basic risk management facilitation methods

  • Informal methods and how to use them

  • Supporting statistical methods

  • And much more!

With this report you’ll learn best practices for proactive QRM, and explore its use at various phases of product lifecycles.

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Table of Contents

  • Introduction
  • Potential Applications and Uses of Quality Risk Management
  • The Quality Risk Management Process
  • Methods and Tools of Quality Risk Management
  • And More …

View the entire TOC

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