Laboratory Controls Overview & Establishment of Specifications

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated “The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing.”  Consistent with current Good Manufacturing Practices (cGMPs), such testing must always be performed using a product specification based on sound scientific principles and approved by the Quality Control unit.

This 90-minute accredited training course will provide participants with a broad understanding of the requirements for establishing a drug product specification that meets these FDA expectations. Current accepted practices of following ICH guidelines for establishing universal and specific tests as well as specifications for organic impurities will be covered.

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.