GAMP CSV Training

• Design Customized Training to directly address the challenges faced during the execution of projects
• Deliver 2-days Train-the-Trainer training on CSV and 3 Days for building technical enhancement to teams by performing CSV activity of Systems on soft floor.
• Prepare training module for CSV Validation, GMP Training, Cleanroom and Sterile Process.
• Prepare Qualification Documents, SOP, Protocols, and Procedures to accomplish the different regulatory requirements.
• Developed training for specialized systems like LIMS, ERP, Track and Trace, Track wise and ASRS systems
• Created and delivered Train-the-Trainer materials, knowledge enhancement, technical writing and knowledge transfer to the targeted attendee.
• Designed and developed training curriculum, courseware for web-based training for end-users.
• Conducted training needs analysis, designed and developed training courses for delivery via online, classroom training and on-field training.
• Developed company-wide pharmaceutical compliance training for GAMP and GMP Services.

Areas Covered for CSV Validation Program

• Which computer systems should be validated?
• Assessing the risk categories for computer systems
• Writing User Requirement specifications
• Defining vendor requirements
• What to test for operational qualification?
• What to revalidate after changes?
• Which documentation should be developed
• Defining Part 11and Annex 11 controls for computer systems