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교육및훈련-교육사진
2016년 상반기 ISPE 정기교육
2016-04-19 by ISPE Korea
ISPE KOREA Affiliate–SGS Co–workshop for Biopharmaceuticals and Testing
( 12 April 2016 am 9:30 - pm 5:00 / 동시통역)
1. Introduction to SGS Capabilities for Pharma/Biopharma Analyses: Testing Summary and Vision. (Fiona Greer)
2. Quality System for GMP & GLP Testing (Jane Horan)
3. Materials and Vendors Evaluation Process and Evaluation Parameters (Jane Horan)
4. Characterization for Cell Banks, Virus Banks, Bulk Harvest and Finished Lot including various adventitious agent tests, RCR, RCL, RCA (Archie Lovatt)
5. The Management and Qualification of Quality Laboratory Test Equipment. (Alan Wilson)
6. Techniques for Characterisation and Comparability of Novel and Biosimilar Biopharmaceutical Products including Analysis for Glycosylation, antibody-drug conjugate, aggregation analysis etc (Fiona Greer)
7. Statistical Approaches for Validation including analytical method validation (Chris Harbach)
8. Leachable / Extractable (Chris Harbach)