Course Content:
- Introduction & Course Objectives
- Regulations and Guidelines for Computer System Validation:
- Current GAMP version a
- FDA and EU regulatory guidelines
- FDA Guidelines Software validation
- Electronic Signatures and Records:
- Background & impact of the regulations ,
- Regulations and practical implications,
- How to assess relevant company systems/products for compliance
- Implementing a validation program around a compliant package.
- The Computer Validation Life Cycle:
- Risk assessment of Computerised systems
- Q&A
- Conclude & Follow Up Process
