Electronic Data Auditing Techniques

Overview:

Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally specifically focussed on electronic data.

Electronic data auditing is the process of examining and evaluating an organization's electronic records and systems to ensure their accuracy, reliability, security, and compliance with relevant standards and regulations. It involves using various techniques and tools to gather evidence, assess risks, and identify potential issues related to data integrity, security, and operational efficiency.

Due to this, the training program is designed for the  personnel working in pharmaceuticals who is dealing with the electronic data and compliance.

Why should you Attend:

The learning objectives are firstly understanding and practical implementation of electronic data auditing techniques so as to avoid the potential non conformities or citations related to data integrity in Pharmaceutical organisations.

How the pharmaceutical professionals can ensure compliance and be able to defend their positions. 

The benefits are, 

• Improved Accuracy and Reliability 
• Improved compliance level
• The Electronic data auditing techniques implementation with compliance approach.

Areas Covered in the Session:

• Brief introduction of the topic and scope of review in pharmaceutical industry
• Know your Trainer
• FDA Citations
• Regulatory Expectations
• Approach to Part 11 requirements
• What and How to Review Electronic Data
• Brief on Audit Trail Review - Contents of Audit Trail, Practical way for implementation, Training requirements
• Probability of Errors and Mitigation Plan
• References 
• Q&A 
• Vote of Thanks and contact details

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical IT compliance
• Global QA
• corporate QA and QC
• IT Personnel working or related to Pharma IT Support