38 DEAD! 1500 INFECTED! PRODUCTION HALTED!….. What will  IMPROPER VALIDATION cost your company?  On Cassette or DVD

New Mexico, 1989-- an outbreak of a  disease called eosinophilia-myalgia syndrome (EMS) occurs causing the deaths of thirty-eight people and infecting over 1,500 more over the next several years. The cause is found to be linked to a dietary, amino acid supplement, L-Tryptophan. The drug had proven to be reliable in the past and the sudden outbreak of EMS that it caused was a fatal puzzle. How did this occur? 

“Introduction to Validation” from Multimedia Arts Productions, Inc., uses this tragedy as a starting point to examine and define the elements of validation and their importance in the drug manufacturing process. It explains the FDA’s reaction to the outbreak and the new restrictions and regulations it imposed, and takes the viewer step by step through the elements that make up the validation process. 

The series examines validation, describes how process specifications, critical process parameters and critical quality attributes are established during R&D, and describes the development of the validation protocol. It examines the importance of validating equipment, computers and cleaning procedures and describes a specific approach to validation. It also stresses the importance of the final validation report the importance of change control and the Periodic
Review. Finally, it imparts a strong understanding to trainees of the importance of validation and their part in maintaining the integrity of quality systems that are put in place to manufacture a safe, effective product.

"Introduction to Validation" is written by Richard Sands, who has had 40 years of experience in validation and pharmaceutical training. He has acquired valuable insight and expertise in the validation process, which he now shares with you.

"Introduction to Validation" is a two video set with an extensive trainer's guide. You will find nothing out there like it. It is a comprehensive introduction to the validation process, and it is a training tool that every company should have in its library.

Item: VAL1           Running time: Appr. 28 min.                               $995.00
or order both the Tape and DVD of this program for an additional $250