Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance 2013

Topics

• Controlling Residual Solvents in Incoming Materials or Those Introduced During Manufacturing
• Introduction to Regulatory Landscape for Residual Solvents
• Strategies for Compliance: Testing and Avoiding Testing
• Analytical Procedures for Residual Solvents: Compendial Procedures, Alternative Procedures and Reference Standards
• Frequently Asked Questions, including Feedback from FDA
• Reporting Residual Solvents: Assuring You Address Regulators` Concerns

Who should Attend

Attendees from drug companies and manufacturing sites, including:

• Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
• Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers
• Analysts
• Laboratory managers and staff
• Training department
• QA/QCU managers and personnel
• Consultants
• Documentation department