Regulatory Submissions 2015

Key Topics

• CTD / TRD - General Design of Facilities and Buildings, Airflows / Air Handlers and Pressure Differentials
• CTD FORMAT FOR EACH SUBMISSION, Quality, Nonclinical Study Reports, Common Technical Document Summaries , Clinical Study Reports – Examples as follows
• CTD / TRD - Generate operational quality minimizing product damage or contamination by Instructing and Training of Personnel, Gowning Procedures and Personnel Flow
• CTD / TRD – Overview of Production (Operation, flow of Equipment and Product)
• CTD / TRD - Detailed Description of Major Equipment, Product Bulk Connections, SIP and Associated Controls-General Overview
• CTD / TRD - Validation /Qualification of all process operations, Computer Systems, building services, stability, etc

Who should Attend

• Regulatory Affairs
• Enior Management
• R&D and Engineering Staff
• Quality Systems Personnel
• Compliance Managers
• New Product Development
• Consultants
• Manufacturing Engineers