TypeOnline Course
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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.

Section 1Core Module
Section 2Core Module
Lecture 2Data Integrity issues in Pharmaceutical Industry
Lecture 3Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 4Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 5RTQs | Response to Queries | How to handle Regulatory Queries  
Section 3Supportive Module
Lecture 6Premises & Plant Layout Designing
Lecture 7Sanitation and Hygiene
Lecture 8Equipment Modules
Lecture 9Production Modules
Lecture 10Documentation
Lecture 11Quality Control
Lecture 12Product Complaint
Lecture 13Storage Module
Lecture 14Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 4Final Examination