This training will help all the candidates about what are the requirements about excel sheet validation, how to perform excel validation and ensure compliance in the organization etc. At the last, we will have brain storming session with Q&A so that, we will able to trigger the thought process in candidates about putting controls on GxP computers.
Overall the candidates will be learning about data integrity requirements with respect to importance of validation of excel spread sheets used in pharmaceutical companies. This Training Course will benefit all who use cGxP computerized systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. Further this course will be helpful to those who are working and related to data integrity and ensure the electronic data ready for inspection.
Areas Covered in the Session :
- Introduction to excel spread sheet
- How to develop GxP compliant spreadsheet applications
- Learn how to use Excel’s built in 21 CFR Part 11 features
- Security related to excel sheets
- Good practices while handing excel sheets for GXP activities
- What standard you should use for validating excel sheets – Calculators – How to calibrate the calculators
- How to Practically perform spread sheet validation – Designing the protocol
- Validation of calculations in excel sheet – Preparing the report and approval
- Understand what does and does not need to be validated
- Reduce validation time and costs
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- IT/IS Departments
- Laboratory Staff
- Engineering Departments
- Software Departments
- Regulatory Affairs Departments
- Quality Technicians and Inspectors
- Project Managers
- Software vendors and suppliers
FDB3522
