Understand the different purpose and scope of GMP documents and regulatory documentation.
What are the different levels of detail in CMC versus GMP documentation?
Understand the concept of Quality by Design development for APIs and finished products.
How should manufacturing processes be described in the CMC dossier compared to the GMP documents? What level of detail is required and recommendable?
How should approvable specifications for APIs and finished products be drafted?
Understand how quality risk management according to ICH Q9 should support product lifecycle from baseline CMC to variations.
What are key activities to ensure regulatory compliance?
How will new and upcoming guidelines impact our business?