Established Condition - The New FDA Guidance 2016

Topics

• Definition of Established Conditions
• Ackground
• Sections of CTD that Typically Contain Established Conditions
• Elements of a Control Strategy that May be Considered Established Conditions
• Changes to Established Conditions
• Establishing Conditions as Part of the Application Submission and Review
• Conclusion

Who should Attend

Senior attendees involved or interested in:

• Regulatory Affairs Teams
• Senior Management
• Quality Assurance Teams
• Compliance Officer
• Change Management Professionals
• Process Engineering Teams
• Validation Specialists