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Data Integrity in Quality Control Laboratories
The major points covered include:
- Introduction to Data Integrity
- FDA Citations
- Non IT – Focus area for data integrity
- IT- Focus area for data integrity
- Some examples of data integrity
- Current trends of inspectors
- Data integrity in Microbiology laboratories – Some examples
Overview of the webinar
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.
The emphasis of all regulators is on the ALCOA++ Plus principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle.
The training on data integrity should be different for different departments, further reviewers should have specific training, supervisors and managers should have specific training and the management should have specific training.
Due to this, the training program is designed for the personnel working in quality control.
Who should attend?
- Officer
- Executives
- Managers
- Global Quality Leaders
- Auditors
- Compliance Experts
- SME's
Why should you attend?
The learning objectives are firstly understanding the data integrity requirements in Pharmaceutical organisations specifically in quality control department.
How Laboratory personnel can ensure compliance and be able to defend their positions.
The benefits are:
- The person’s understanding about data integrity will be clear.
- The person working in production will become vigilant while generating and handling the data.
- The data integrity awareness will be increase in the company.
Faculty - Mr.Hitendra Kumar Shah
A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc.