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게시판-공지사항
2016년 ISPE 한국지부 상반기 정기과정
2016-02-04 by ISPE Korea
첨부문서 : 2016년 상반기 교육안내_2016.04.12.pdf (106 KB) 첨부문서 : 교육신청서_2016.04.12.doc (453 KB)ISPE KOREA Affiliate-SGS Co-workshop
for Biopharmaceuticals and Testing
Topics for the Workshop : one day sessions (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)
교육신청 및 기타
교육신청
- www.ispe.or.kr > 교육 및 훈련 > 교육과정신청
- Fax : 043-216-0445 (교육신청서)
- E-mail : ispe@hanmail.net (교육신청서) / ispekorea@ispe.or.kr (교육신청서)
교 육 비
- 25만원(유료회원15만원), 신한100-029-372879아이에스피이코리아
- 세금계산서 발급(사업자등록증 사본 보내주세요)
제 공
수료증, 중식, 교재
교육장소
한국제약협회 대강의실
주관/주최
ISPE 한국지부
문의 : ISPE 한국지부 (043-213-0442)