Data Integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
Why Should You Attend:
In their guidance on Data Integrity, all regulators emphasize a risk-based approach to ensure that effort is focused on the greatest risks. This approach should help companies to achieve compliance with regulators’ expectations without committing a disproportionate amount of human or financial resource. This webinar will explain to attendees why data integrity is so important and spell out some of the common honest mistakes that could lead to regulatory enforcement action. The risk-based approach recommended by regulators is also explained in detail.
Areas Covered in the Webinar:
- Data Integrity myths
- Historical background
- Definition of data integrity
- Current regulatory approach
- Guidance
- Static and dynamic records
- Non-conformance trends
- Example enforcement letters
- Data integrity risks in the analytical process
- Conducting a data integrity risk assessment
- Common causes of data integrity breaches
- Practical tips on achieving compliance
Who Will Benefit:
- Quality assurance professionals
- Consultants
- GMP auditors
- Laboratory management
- Contract laboratories
- Personnel responsible for data review
From Pharmaceutical manufacturers, contract laboratories
