The role of an integrated LIMS solution on supporting data integrity in current good manufacturing practice (cGMP) environments
ABOUT THIS WEBINAR
The US FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP1 that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’. In fact, 21 out of 28 warning letters issued by the agency between January 2015 and May 2016 involved data integrity issues in drug manufacturing.2
Ultimately, whether you are a drug manufacturer, clinical research organisation (CRO) or pharmaceutical R&D company, FDA compliance as well as the accuracy and completeness of data is critical for safe product development, and any breach of data integrity could have serious implications for human health.
During this on-demand webinar, we consider and clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs as required in 21 CFR parts 210, 211 and 212. We also discuss how a LIMS can aid your compliance efforts and enhance the value of your data.
- Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
- Current Expectations and Guidance, including DataIntegrity and Compliance With CGMP
Watch this webinar and learn more about:
- Why is Data Integrity important?
- What is Data Integrity?
- Manual laboratory workflows
- How a Laboratory Information Management System (LIMS) can aid your compliance
- How a LIMS can support your organisation on saving time and money
- How STARLIMS can enhance the value of your data.
Tamara McKenna, Sales Executive & Accounts Manager, Abbott Informatics
After graduating from University of the Witwatersrand with a BSc (Hons) in Chemistry, Tamara spent some time working as a process metallurgist, in both hydrometallurgical processing and thermochemistry for a mining research and technology business, before moving into the LIMS industry where she has been for the past 18 years. Prior to taking on a business sales role Tamara was involved in implementation and project management of LIMS applications in a diverse range of industries and laboratories.