With the recent increase in data integrity findings ranging from falsification of study data to mishandling of batch production records, and misbranded products due to insufficient information on labels, do you know if your lab is ready for a data integrity audit? Do you know what the FDA is looking for with respect to data integrity and your laboratory informatics systems?
In one hour, learn how you can start preparing your lab for a data integrity audit of informatics systems and lab processes. Join our professional experts as they explore the key elements of the FDA Data Integrity and Compliance with CGMP Questions and Answers Guidance for Industry. Learn where to focus efforts to answer the critical questions that an auditor may ask during an audit, and how best to prepare for a data integrity audit.
* Learn how your informatics systems might be involved in an audit and why
* Understand some key areas of focus for data integrity
* Techniques for performing successful internal data integrity audits
* Common pitfalls in data integrity compliance
* Resources for preparing for an audit
* Laboratory Managers/Directors
* Laboratory Informatics System Owners
* Software Validation Analyst and team members
* Quality Control and Quality Assurance
You will have the opportunity to speak directly with a Software Validation expert and receive real-time answers. Take home ideas to prepare your lab for data integrity audits.
This is a complimentary hour-long presentation including a Q & A section.