Introduction
Training Areas
Feature
Who should attend
Related Courses
Data integrity online training course is provide basic fundamental know-how about data integrity issues of pharma, biopharma and medical devices companies. This online course will help to understand the concept of data integrity, interpreting expectations of regulatory agencies. Moreover, the course helps to understand major data integrity issues practically to avoid future mistakes.
This interactive online certification course empowers professionals to grasp the fundamentals of data integrity, master AI-driven practices, and apply practical solutions to ensure compliance and avoid costly mistakes. Special emphasis is given to Audit Trail Management, a core focus area in recent regulatory inspections.
Data Integrity + AI = Compliance Confidence | Master audit trails, governance & AI-driven integrity checks.
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.
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
Course Snapshots
- Course Code: RYD-033
- Title of the course: Fundamental Training on Data Integrity in pharmaceutical, Biopharmaceutical and Medical Devices industry.
- Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
- Duration: 3 Days Microlearning Course.
- Eligibility: Graduation in any discipline. Even the final year student can join the course.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
Key training areas
- Understand the importance of data integrity in regulated industries
- Recognize the impact of DI issues on compliance, product quality, and patient safety
- Integrate data governance into Quality Systems effectively
- Gain exposure to practical DI problem areas and learn to mitigate risks
- Distinguish between human error vs. falsification or fraud
- Apply the principles of Data Integrity Management (ALCOA+ and ALCOA++)
- Identify data lifecycle elements for both manual (paper) and electronic records
- Spot risks and weaknesses linked to poor data control
- Incorporate data integrity aspects into equipment design & qualification
- Explore the role of Artificial Intelligence in enhancing DI compliance
Key features of the course
- AI-Integrated Training: Learn how Artificial Intelligence can transform DI monitoring & reporting
- ️ Hands-On Focus: Practical exposure to real-world DI issues & case studies
- Audit Trail Mastery: Deep dive into audit trail design, review & compliance expectations
- Global Compliance Insights: Align with FDA, EMA, MHRA & other key agency requirements
- Flexible eLearning: 100% online, self-paced learning with 24×7 access
- Certification: Royed Training Certificate upon successful completion
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.
