Introduction
Course Type
Course Duration
Feature
Eligibility
Who should attend
Certification
Course Deliverable
Related Courses
About data integrity
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.
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
The short Certification course is designed to provided comprehensive understanding on data integrity in pharmaceutical and biopharmaceutical industry.Â
Course Code: RYD-033
Course Title: Fundamental Training on Data Integrity in pharmaceutical, Biopharmaceutical and Medical Devices industry
Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
3 days.
Key features of the course
- 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
- Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.Â
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.Â
Anyone who want to enhance knowledge about data integrity and get certified, can attend the course.
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.
 Certificate will be provided at the end of the successful completion of the course.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
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What is data integrity issues in pharmaceutical, biopharmaceutical and medical devices industry?
Data integrity is the maintenance and the assurance of the accuracy and consistency of data over its entire life-cycle. It’s a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
About data integrity >> Learn more
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