GMP Forum

GBC 9

GMP Forum

09:00 ~ 18:00 Orchid 2F

Summary
We share recent information over the process management for manufacturing and provision of medicines globally in order to ensure quality products.
Date
June 28(Thu), 09:00 ~ 18:00
Venue
Orchid 2F Venue Guide

Schedule

Time Title Presentation File
GMP
Chair : Chung Keel Lee (MFDS)
09:30~10:20(50')

Practical Approaches to Laboratory Data Integrity

Charlie Wakeham / Waters

10:20~11:10(50')

A risk-Based Approach to Computerized Systems Validation

Charlie Wakeham / Waters

11:10~11:50(40')

Current Approaches and Strategies towards Data Integrity

Richard W. Lee / Samsung BioLogics

11:50~12:10(20')

Q & A

-
Chair : Chan-Wha Kim (Korea University)
13:30~14:20(50')

Data analytics brings increasing value to biopharmaceutical development and manufacturing

David Wang / Sartorius

14:20~15:10(50')

ADC Manufacturing Process and Quality Control: BesponsaTM

Tok Han / Pfizer

15:10~15:25(15')

Q & A

-
15:25~15:40(15')

Coffee Break

-
15:40~17:10(90')

Prefilled Syringe and Injection Device – evolving to ensure pharma companies’ life cycle management

Herve SOUKIASSIAN / Becton Dickins

17:10~17:25(15')

Q & A

-