Process Validation – ISO 11607 FDA

MMP’s on-line Process Validation – ISO 11607 FDA course consists of 48 modules (total expected time = 48 hours).  ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging.  This course will prepare you for, “what exactly needs to be done” for a successful process validation.  This course includes discussions concerning repeatability and reproducibility studies as well as the analytical tools needed to successfully conduct such validation studies.  Process validation studies are a requirement in regulated industries such as medical device and pharmaceutical. Students who successfully complete all class requirements will receive their GSIP certification.

 

ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging.  This course will prepare you for, “what exactly needs to be done”.  It is widely known that test procedures published by organizations such as the United States Pharmacopeia (USP), American Society of Tests and Measurements (ASTM), and the International Organization of Standard (ISO) are critical to the manufacture, qualification, and approval of FDA regulated products.

 

Time: 25 hours lecture time + 9 hours testing time + 14 hours for project = 48 hours

Price: $750

 

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