GMP Compliance Chapter - Change Control, Out-of Specification Investigations and CAPA 2013

Topics

• Optimizing Change Control Program
• Regulatory Requirements of Change Control
• Evaluation of the Change Proposal
• Planning and the Initiation of a Change Proposal
• Change Control Documentation Requirements
• Change Control Implementation
• Developing an effective change control form
• Developing a Harmonized Change Control Procedure
• Benefits for having Establishing a Robust Change Control Program
• Post Implementation — Monitoring and Maintaining a Change Control Program

Who should Attend

• Change Control
• QA/QC
• Validation
• Manufacturing/Production
• Production Engineering
• Regulatory Affairs
• Validation
• GMP Compliance
• Lab Operations
• Process Development
• Suppliers
• Consultants