The FDA has begun to more closely scrutinize the industry's effort in the qualification of suppliers and contractors. This is particularly true in the qualification of the supplier for a reduced testing program. When properly administered, a reduced testing program lowers the cost of testing and provides a higher level of quality.
The principles for pharmaceuticals and medical devices are the same but there are some differences due to the nature of the products.
This course will help you understand FDA expectations for reduced testing of components and will develop your confidence in maintaining control of supplier quality. This discussion begins with explaining, in stepwise fashion, the various steps required to have a successful reduced testing program. The primary steps include material qualification, general supplier qualification, supplier qualification for reduced testing, establishing criteria for sampling, the role of the laboratory, test methods, comparing analytical results, and determining the Certificate of Analysis (COA).
The principles for pharmaceuticals and medical devices are the same but there are some differences due to the nature of the products.
This course will help you understand FDA expectations for reduced testing of components and will develop your confidence in maintaining control of supplier quality. This discussion begins with explaining, in stepwise fashion, the various steps required to have a successful reduced testing program. The primary steps include material qualification, general supplier qualification, supplier qualification for reduced testing, establishing criteria for sampling, the role of the laboratory, test methods, comparing analytical results, and determining the Certificate of Analysis (COA).
