Computer System Compliance Training Programs
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.
Our training programs are customized to meet each organization's requirements. The challenge always is to make all stakeholders understand importance of regulations and benefits of proactively being computer system compliant and we become bridge across the cross functional teams to ensure that the knowledge and practices reach to grass root levels.
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.
- 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
Train The Trainer
Our this program assist clients to develop an internal resource pool who become champions of the CS compliance. The program continue to equip experienced trainers with the skills necessary to deliver relevant and latest contents to internal audiences. Our program covers the following.
- Computer System Compliance Contents creation/enhancements
- Coach/mentor identified internal ‘trainers’ or ‘auditors’
- Upgrade the compliance knowledge by classroom trainings, case-studies, group discussions
- Create an assessment bank
- Periodic evaluation of Trainers and assistance for overcoming challenges
All these we can integrate with client’s existing TMS or LMS platform so client can continuously reap the benefits of the program.
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