cGMP Training Seminar for the Biotechnology and Pharmaceutical Industries - Europe
22 April 2004 - 23 April 2004
This seminar is tailored for those individuals responsible for achieving and maintaining a state of compliance with international cGMP requirements, specifically the European Agency for the Evaluation of Medicinal Products (EMEA) and the Food and Drug Administration (FDA).
WHO SHOULD ATTEND:
- Those responsible for achieving and maintaining a state of compliance with international cGMP requirements related to the biotechnology and pharmaceutical industries, specifically the European Agency for the Evaluation of Medicinal Products (EMEA) and the Food and Drug Administration (FDA).
- Personnel associated with supply companies.
- Professionals responsible for Compliance, Regulatory Affairs, Project Planning, Technology Transfer, Quality Assurance, Quality Control, Research & Development, and Manufacturing.
SEMINAR TOPICS COVERED: ,- Introduction to cGMPs and the FDA,- Raw Materials, Laboratory and Process Controls,- Quality Concepts; Organization of the Quality Unit,- Labeling and Identification,- GLPs,- Cleaning; Cross-contamination Prevention,- cGMP Documentation; Validation Issues,- Inspection and Investigations,- Gowning Procedures,- International cGMPs,- Standard Operating Procedures and Batch Records,- New trends in cGMP compliance, ,Sponsored by: SPI USA, Inc.,Contact Information:,Location: London, UK; Renaissance London; Chancery Court Hotel,Mr. Elia Cossis, Event Coordinator,e-mail: ecossis@usaspi.com,website: http://www.spi.pt/seminar,Tel(opens in new window): +1 410.997.5600
WHO SHOULD ATTEND:
- Those responsible for achieving and maintaining a state of compliance with international cGMP requirements related to the biotechnology and pharmaceutical industries, specifically the European Agency for the Evaluation of Medicinal Products (EMEA) and the Food and Drug Administration (FDA).
- Personnel associated with supply companies.
- Professionals responsible for Compliance, Regulatory Affairs, Project Planning, Technology Transfer, Quality Assurance, Quality Control, Research & Development, and Manufacturing.
SEMINAR TOPICS COVERED: ,- Introduction to cGMPs and the FDA,- Raw Materials, Laboratory and Process Controls,- Quality Concepts; Organization of the Quality Unit,- Labeling and Identification,- GLPs,- Cleaning; Cross-contamination Prevention,- cGMP Documentation; Validation Issues,- Inspection and Investigations,- Gowning Procedures,- International cGMPs,- Standard Operating Procedures and Batch Records,- New trends in cGMP compliance, ,Sponsored by: SPI USA, Inc.,Contact Information:,Location: London, UK; Renaissance London; Chancery Court Hotel,Mr. Elia Cossis, Event Coordinator,e-mail: ecossis@usaspi.com,website: http://www.spi.pt/seminar,Tel(opens in new window): +1 410.997.5600