Conference Description:

The FDA has increasingly observed cGMP violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs.


Importance of this workshop:

If you receive a Warning Letter pertaining to Data Integrity or your firm is placed on the Import Alert List, you may have to stop manufacturing, recall your products, train all of your employees, validate your manufacturing processes, validate your data, testing methods and re-qualify your equipment. You will also be required to hire consultants.


Who Should Attend:

Quality Departments
Regulatory Affairs Departments
Compliance Departments
Research and Development Departments
Engineering Departments
Manufacturing Departments
Production Departments
Operations Departments
Validation Departments