This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. Further we are ensuring to make you understand about the new FDA expectations for computer software assurance (CSA).
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course will provide principles and an overview of the overall computer systems compliance.
Who Will Benefit:
This CSV and CSA Training Course will benefit all who use cGXP computerised 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.
- Regulatory Affairs
- QA/ QC
- Software Managers
- Project Managers
- Software vendors and suppliers
What will you learn
- This course will provide principles and an overview of the overall computer systems compliance
- This workshop de-mystifies computer system validation approach and sets out the principles which would equip the quality and technology professionals
- The workshop enables a pragmatic and consistent understanding of CSV and Data Integrity requirements
- It will benefit all who use cGXP computerised systems to perform their job functions