Webinar ID:   ICT134

Excel Spreadsheet Validation in GxP Environment

ON-DEMAND
  2 Hours

Categories:   Uncategorised,

Computers are being used in all organizations. Where the Microsoft word and excel documents are routinely used for GxP activities. When we are using Microsoft excel spread sheet for GxP activities, it is essential to validate it. If the excel spreadsheet is not validated, it will lead to non-conformance for the organizations.

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 computer also.

Overall the candidates will be learning about data integrity requirements with respect to importance of validation of excel spread sheets used in pharmaceutical companies.

Areas Covered in the Session :

  • Introduction with respect to excel spread sheet, why Microsoft excel is also called as spread sheet.
  • 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.
  • Interactive Q&A Session

Who Should Attend:

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.

  • Quality Assurance Departments
  • Quality Control Departments
  • IT/IS Departments
  • Engineering Departments
  • Software Departments
  • Regulatory Affairs Departments
  • Quality Technicians and Inspectors
  • Project Managers
  • Software vendors and suppliers

ICT134

HitendraKumar Shah

Hitendrakumar Shah is a renown 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 the CEO of NADH+ GxP Compliance Services and a popular figure on social media for his effective and easily understandable training bites.