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
