Quality Committee Symposium on Quality Assurance of Sterile Pharmaceuticals and Latest GMP Inspection Trends

Date and Time

Saturday, November 16, 2019 13:00 - 17:00 Ino Hall

Program

Click here for the program (238KB)

Presentation materials

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	Presentation	Speaker
Key Points of PIC/S GMP Annex 1 Revision	01_SUMMARY OF REVISING ANNEX 1 & Discussed Points During Revision（3.1MB)	Ms. Tracy Moore (UK-MHRA) Mr. Abdelaali Sarakha (FR-ANSM)
Perspectives on Inspections in Sterile Pharmaceuticals from Inspectors in the U.S., Europe and Japan 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)
Intermission
Panel Discussion "Trends of 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 Medicine Inspection System（1.4MB)	Ms. Andrea Geyer (BRA-ANVISA)
	12_Overview of Inspection Process PMDA (396KB)	Mr. Tetsuhito Takarada (JPN-PMDA)
	13_Saudi FDA GMP Inspection Overviewf (1.2MB)	Mr. Mohammed Ali Dahhas (SAU-SFDA)

The End