VALİDASYON SEMİNERİ 2003
TRAINING COURSE - “GMP COMPLIANCE FOR COMPUTERIZED SYSTEMS VALIDATION”
16-17 January 2003 Istanbul

Laws, Regulations and PIC/S Guidelines for CSV Beat Jenny

Industry Guidelines (GAMP 4, PDA Tech. Reports) Wolfgang Schumacher

The Computer Validation Life Cycle Günter Generlich/Wolfgang Schumacher

Validation Planning Günter Generlich/Wolfgang Schumacher

User Requirements Specifications  Günter Generlich

Risk Assessment  Günter Generlich / Wolfgang Schumacher

Practical Approach To Risk Assessment & Taxonomy Of Software Risks Günter Generlich / Wolfgang Schumacher

Risk Information Form Günter Generlich / Wolfgang Schumacher

GxP in the IT Department Wolfgang Schumacher

Testing A Günter Generlich

Testing B Günter Generlich

Change Control Wolfgang Schumacher

Change Request Form Schumacher

Electronic Records and Signatures (21 CFR Part 11) Wolfgang Schumacher/Beat Jenny   Supplier Audits Günter Generlich

Validation Documentation Günter Generlich

Benefits and limits of CSV Regulatory Comments Discussion of open questions Beat Jenny / Günter Generlich / Wolfgang Schumacher