Excel Spreadsheet Validation In GxP Environment

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


HitendraKumar Shah

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.

  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance