Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer 2017

Topics

• The different methods required for various drug products and the types of impurities which must be addressed
• The lifecycle approach to method development and validation
• Use an IQ/OQ/PQ approach to method qualification
• Identify an ATP for methods being developed
• Comply with compendial requirements with greater success and fewer resources
• Develop appropriate protocols for method transfer

Who should Attend

• Regulatory Affairs/CMC Personnel
• Chemists (Research, Quality Control, CRO)
• Analysts
• Laboratory Managers and Staff
• QA/QC Managers and Personnel