Regulatory Document – Site Master File 2016

Topics

• Purpose and scope of Site master File
• Introduction to Site master File
• General information on the manufacturer
• Content of Site Master File
• Personnel
• Quality management system of the manufacturer
• Documentation
• Premises and equipment
• Quality control (QC)
• Production
• Self inspections
• Distribution, complaints, product defects and recalls

Who should Attend

• VPs
• CEOs
• Attorneys
• Compliance Officers
• Quality Assurance
• Regulatory Affairs
• Validation Department
• R&D
• Consultants
• Manufacturing Engineers
• Anyone interested in understanding the regulations requirements