- 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
