Handling OOS Test Results and Completing Robust Investigations

It was the Barr Decision in the early 1990s that first coined the term “Out-of-Specification (OOS).” Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not performing an adequate investigation.

This 90-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

THIS TRAINING IS PART OF OUR GMP LABORATORY CONTROL PROFESSIONAL CERTIFICATION

• To enroll into the complete GMP Laboratory Control Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications 

​To register for this individual course ONLY, click the Register Now button below.