Computer System and IT has become very crucial for the modern day pharmaceutical enterprises. Computers and IT no longer remains a mere support tool; it has become a crucial compliance proposition for many organizations. Computer System Compliance has evolved in last decade to become an integral part of GxP requirements. While the methodology has developed and matured with latest version of GAMP (5) guidelines, the complexity of software technology still leaves a gap between the Regulatory Expectations and the awareness and knowledge at working level executives.
We offer a full complement of training programs on Computer System Compliance. Our training programs can be customized to meet each organization's requirements. In addition training seminars, we are also providing classroom training.
The Training faculties carry a rich experience in fields related to CSV validation, GAMP 5 based validation documentation and current interpretation of International regulations i.e. US FDA 21 CFR Part 11, EU Annexure 11 etc. The focus of training is always on real time applications. We strongly believe that technical knowledge has to be complemented with its application and use in the real world and the course content has also been designed accordingly.
Benefits of Using Epitome for Compliance Training
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- Experience with GxP Requirements- Our faculties are experts at compliance issues with years of real-world experience. Let our experience provide you with a firm foundation when dealing with CSV and 21 CFR Part 11
- Improved Value to your Quality Systems - Effectively integrate existing documentation with Computer System documentation thus avoiding duplication or repetition and achieve consistency with your QMS.
- Risk-based Approach to Computer system Validation
- Understand and achieve 21 CFR Part 11 compliance
- Achieve EU Annexure 11 Compliance
- GAMP 5 based Life Cycle Management
- GxP Testing
- Data Integrity and CSV
- SAP Validation
- Lab Validation and Data Integrity
- How to face an audit
- Understanding need of Computer System Validation
- Evolution of GAMP and Current guidelines
- Automation and IT in Pharmaceutical Industry
- Understanding US FDA 21 CFR Part 11 compliance
- Understanding EU Annexure 11 compliance
- Preparation of Test Protocols and Test Scripts
- GAMP 5 based life cyle documentation and SOPs