Ensure regulatory compliance and maintain data integrity through effective auditing of laboratory data systems. Join our informative webinar, where we delve into the crucial aspects of auditing to meet the expectations of regulatory agencies. Gain detailed insights into the most common non-conformances and equip staff members, even those unfamiliar with laboratory computer systems, with a comprehensive understanding of the necessary controls to ensure the integrity of analytical data.
This webinar is designed to educate participants on the importance of correct data system configuration and provide guidance on what to look for during the audit process. By implementing the knowledge gained, businesses can effectively reduce the risk of regulatory action resulting from non-compliance with current expectations, safeguarding their operations and reputation. Don't miss this invaluable opportunity to enhance your auditing practices and align with regulatory requirements.
Areas Covered in the Session :
- Categories of laboratory data system (GAMP)
- Lifecycle management, archiving and backup
- What counts as raw data?
- Protecting the integrity of analytical data
- General guidance on assigning user privileges
- Operating system configuration.
- Application configuration
- Controls appropriate for chromatography data systems
- Practices that aid compliance with data integrity requirements
- Examples from recent FDA warning letters
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Staff who are required to audit analytical operations who do not have a chemical QC background
- Auditors who require updating on current regulatory expectations
- QC staff who needs help in regulatory compliance
- Staff who would like to understand the implications of data integrity for laboratory data systems
Course Director: KELLY THOMAS
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.