Quality & Technology Committee Symposium on Quality Assurance for Sterile Pharmaceuticals and the Latest Trends in GMP Inspections

Date and Time

Saturday, November 16, 2019, 1:00 PM – 5:00 PM, Iino Hall

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	Presentation	Speakers
Key Points of the Revision to PIC/S GMP Annex 1	01_SUMMARY OF REVISIONS TO ANNEX 1 & Points Discussed During the Revision (3.1MB)	Ms. Tracy Moore (UK-MHRA) Mr. Abdelaali Sarakha (FR-ANSM)
Inspection Perspectives on Sterile Drug Products from Inspectors in the U.S., Europe, and Japan	02_cGMP Inspectional Deficiencies for Sterile Drug Products (1MB)	Ms. Ileana Barretto-Pettit (US-FDA)
	03_Observation and Inspection Points for Sterile Products (1.9MB)	Mr. Abdelaali Sarakha (FR-ANSM)
	04_MHRA Inspection Findings - Sterile Products (889KB)	Ms. Tracy Moore (UK-MHRA)
	05_The Symposium on "PIC/S GMP Annex 1 and Relevant GMP Inspections" (744KB)	Mr. Tetsuhito Takarada (JPN-PMDA)
Break
Panel Discussion: “Trends in GMP Inspections”	06_MHRA GMP Inspections (716KB)	Ms. Tracy Moore (UK-MHRA)
	07_ANSM GMP Inspection Overview (1.7MB)	Mr. Abdelaali Sarakha (FR-ANSM)
	08_GMP Inspection Overview: U.S. Food and Drug Administration (332KB)	Ms. Ileana Barreto-Pettit (US-FDA)
	09_The Russian GMP Inspectorate: Inspection Experience and Review of Inspections (1.1MB)	Ms. Elena Denisova (RUS-MIT) Ms. Tatiana Nikolko (RUS-SID&GP)
	11_ANVISA and the Brazilian Medicines Inspection System (1.4MB)	Ms. Andrea Geyer (BRA-ANVISA)
	12_Overview of the PMDA Inspection Process (396KB)	Mr. Tetsuhito Takarada (JPN-PMDA)
	13_Overview of Saudi FDA GMP Inspections (1.2MB)	Mr. Mohammed Ali Dahhas (SAU-SFDA)