HOW DO MANUFACTURERS “READINESS PREPARE” BEFORE A REGULATORY AGENCY’S INSPECTION?
Lecture: What is a PMDA’s Inspection?
Lecture: What is an FDA’s CGMP Inspection?
Discussion “Good strategy in front of Inspectors: Our experience”
Lecture: Design Procedure for Chemical Hazards API
Lecture: “CSV: How to utilize Software & Computer Systems in compliance with GMP”
Workshop: Case study 1: How to respond to Inspectional Observations?
Workshop: Case study 2: How to respond to Inspectional Observations?
Workshop: What should we do for Eye drop factory (EU GMP Annex 1：Sterile Products)
Workshop: Practical Steps Towards Industry 4.0 for GMP Regulated Companies