Data Integrity is gaining importance day by day in the pharmaceutical, biopharmaceutical and medical devices industry. In cGMP, with both the FDA and European Regulatory Agencies placing a high degree of focus on the subject. This online course will help to understand the concept of data integrity, interpreting expectations, understanding major data integrity issues practically to avoid future mistakes. Course is also focused in detail regarding audit trail.
The 1 Week short Certification course is designed to provided comprehensive understanding on data integrity in pharmaceutical and biopharmaceutical industry.
Course Code: KPE-C-077
Course Title: Fundamental Training on Data Integrity in pharmaceutical and biopharmaceutical industry
Duration: 7 Days
Learning Objectives:
- Understand the importance of data integrity in pharmaceutical and biopharmaceutical industry
- Impact of data integrity issues in pharmaceutical industry
- Know how to integrate data governance into your quality systems
- Exposure to practical areas of data integrity
- Understand the difference between mistakes and falsification or fraud
- Principle of data integrity management
- Be able to identify the data lifecycle elements for both manual (paper) and electronic data
- Understand the potential risks and weaknesses associated with the lack of control of data
- Know how to incorporate the aspects of data integrity into the design and qualification of new equipment
Who will Benefit:
- Person working in the pharmaceutical manufacturing department / F&D personnel
- Regulatory Affairs personnel
- Research and Development personnel
- Quality Assurance & Control personnel
- Development and Preparation of Submission Materials
- Strategic management personnel
- Personnel who involved in internal audit.
Certification: Certificate will be provided at the end of the course after completion of the final examination.
