The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data.
The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations.
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:
- 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: DR. MARK POWELL
Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.
He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.