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Dublin, July 5, 2021 (Global News Service) – “Life cycle management of analytical methods and procedures-training according to new FDA and USP guidelines” The meeting has been added to ResearchAndMarkets.com provide.
This two-day course will explain the background of the new analytical procedure life cycle guide and provide participants with the knowledge needed to implement the recommended methods.
The results of analytical methods are used as the basis for important decisions in the development and manufacturing of pharmaceutical products. All regulatory agencies hope that the pharmaceutical industry will develop appropriate procedures to ensure that the reliability, accuracy, and precision of such methods reach the appropriate level. These procedures should cover the life cycle stages from design, development, verification to continuous daily use.
Recent FDA guidance documents and stimulus articles published by USP have recommended the management of analytical methods and procedures based on a life cycle approach. For example, the recent FDA guideline “Analytical Procedures and Method Validation for Drugs and Biological Agents” contains a part of analytical procedure life cycle management, and ICH recently issued guidelines on product life cycle management.
learning target:
- Understand the regulatory background and recommendations of management analysis methods and program life cycles
- Understand current and future industry trends: the concept of analytical method lifecycle management, the most recent USP General Chapter 1210 (Statistical Tools for Program Validation), and Quality of Design (QbD) principles for method development and validation
- Know how to plan, execute and document the design, development and verification of internal development methods
- Understand the life cycle management principles of pharmacopoeial procedures and…
The full story on Benzinga.com
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