cGMP Training for Biotechnology and Pharmaceutical Industries in Europe - U.S FDA Perspective
22 Aprile 2004 - 23 Aprile 2004
United Kingdom
Two-day training seminar in London, UK: April 22 and 23, 2004,http://www.spi.pt/seminar
cGMP SEMINAR TOPICS:,- Introduction to cGMPs and the FDA ,- Raw Materials, Laboratory and Process Control ,- Quality Concepts; Organization of the Quality Unit ,- Labeling & Identification ,- GLPs ,- Cleaning; Cross-contamination Prevention ,- cGMP Documentation; Validation Issues ,- Inspections & Investigations ,- Gowning Procedures ,- International cGMPs ,- Standard Operating Procedures and Batch Records ,- New trends in cGMP compliance
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
,
cGMP SEMINAR TOPICS:,- Introduction to cGMPs and the FDA ,- Raw Materials, Laboratory and Process Control ,- Quality Concepts; Organization of the Quality Unit ,- Labeling & Identification ,- GLPs ,- Cleaning; Cross-contamination Prevention ,- cGMP Documentation; Validation Issues ,- Inspections & Investigations ,- Gowning Procedures ,- International cGMPs ,- Standard Operating Procedures and Batch Records ,- New trends in cGMP compliance
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
,