Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines is a conference dedicated to methods tha are used as the basis for important decisions during development and manufacturing of pharmaceutical products.

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines covers topics such as:

  • Current and future industry trends: the concept of lifecycle management of analytical methods, recent USP General Chapter 1210 (Statistical Tools for Procedure Validation), and Quality by Design (QbD) principles for method development and validation
  • The regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
  • The principles of lifecycle management for compendial procedures and for managing method transfer
  • How to plan , execute and document design , development and validation of methods developed in-house
  • Risk management strategies throughout the procedure lifecycle
  • Develop a strategy for analytical procedure lifecycle management
  • Justify and document decisions about type and extend of revalidation after method changes
  • The concept of measurement uncertainty
  • Develop inspection-ready documentation during on-going routine operation
  • Define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
  • What questions will be asked during audits and inspections and how to answer them

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines brings together:

  • Quality control scientists
  • QA managers and personnel
  • Analytical chemists
  • Method development scientists
  • Laboratory managers and supervisors
  • Validation specialists
  • Training departments
  • Regulatory affairs professionals
  • Consultants
  • Documentation departments

Future Events

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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