Advanced Regulatory Affairs Training – focus on CMC/Quality Part

Learning Objectives:

After completing this 2-days training course, participants will be able to:

• Understand different types of API submissions (DMF, CEP or Complete 3.2.S).
• Identify documentations required for API and FPP manufacturing processes including API general properties, API & FPP manufacturing process and controls, studies conducted to identify API chemical structure as well as potential API polymorphic forms and process validation requirements for both API & FPP.
• Recognize API and FPP potential and actual impurities (organic, inorganic, genotoxic impurities, degradation products, residual solvents, and heavy metals) and comprehend their possible control strategies.
• Understand how to Set API & FPP specifications & analytical procedures as well as validation of these analytical procedures.
• Define the Requirements on container closure system and stability data for both API & FPP.
• Make use of references to assess the appropriateness of eCTD documentations (e,g, SFDA guidelines, ICH guidelines, Pharmacopeias, USFDA & EMA related guidelines)