ICH Q11 – API Manufacturing Workshop 2018

Topics

• Process controls
• Manufacturing process development
• Control strategy
• Selection of starting materials
• Batch Records
• Standard Operating Procedures
• Submission of information (eCTD)
• Process validation evaluation
• ECTD
• Life cycle management

Who should Attend

• Quality Control Teams
• Quality Assurance Teams
• Microbiologists
• Chemists
• Design Engineering Teams
• Process Engineering Teams
• Manufacturing Teams
• Process Automation Teams
• Validation Teams
• Operations Teams
• Regulatory Affairs Teams
• Utility Operations Teams
• Production Teams