Data Integrity Auditor Masterclass Training Course

Course overview

Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent years, its history dates back approximately 30 years. Data integrity breaches at Barr Laboratories and later Able reveal this issue is older than it seems. As the health authorities began to question data integrity in audits more and more, pharmaceutical manufacturers started to increase their focus on data integrity, especially in GMP audits, and they started to seek ways to train their internal audit teams with this in mind. This approach acts to detect the deficiencies and deviations that will be found in internal audits prior to the health authority audits.

Although there are numerous data integrity training courses available, the training rarely discusses the audits in detail, which leaves companies trying to solve their problems with a little guesswork based on their own knowledge and experience.

In this course, the concept of data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed. The programme will also advise in which departments data integrity audits should be carried out. Data integrity audits of the; warehouse, production, quality control, quality assurance, critical utilities, and engineering departments in pharmaceutical production facilities will be covered, with sample applications and question lists, and the most critical audit findings encountered in health authority audits will be examined. During this two-day training programme, the participants will analyse case studies and scenarios, which will aid the learning process.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

• Learn the requirements of data integrity audits and health authority expectations
• Evaluate the concept of data integrity from a completely different perspective
• Understand the requirements of the role and necessary skills of the data integrity auditor
• Explore how to audit and prepare for external data integrity audits in the following departments; warehouse, manufacturing, quality control, quality assurance, critical utilities, and engineering

At the end of the course, there will be a short assessment exam with case studies and audit scenarios which will be analysed during the course, and those delegates who are successful in the assessment exam will receive the title of ‘Certified Data Integrity Auditor’.

Who should attend?

Personnel from the following departments will benefit from this course:

• Quality assurance and quality control
• Validation
• R&D
• Audit
• Regulatory
• IT
• Warehouse and supply chain
• Engineering
• Procurement 

As well as:

• Health authority inspectors

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