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.

Topics

• 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

Who should Attend

• 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