The Center for Professional Advancement, Amsterdam
24-26 September 2007
Who Should Attend:
This advanced course is designed for individuals responsible for validation, commissioning, construction, or design who need a thorough understanding of the Validation and Commissioning Process for approved pharmaceutical/biopharmaceutical manufacturing facilities. The course will benefit individuals in:Engineering
Quality Control/Assurance
Production
Technical Services/Validation
Regulatory Affairs Pharmaceutical Industry Service Providers will also find this course beneficial.
Description:
Because validation is the critical factor in achieving FDA approval of new and renovated facilities, it is essential that validated systems and equipment be commissioned using GEP in a manner to facilitate the validation process. This course will cover what has become the traditional approach to conduct Qualification and Validation, and will also show how that approach supports the new Regulatory Science and Risk Based Approach for the 21st Century. Current industry application of the impact assessment process for utility systems and equipment will be covered, and assessment results on Master Plans will be explained. The course demonstrates the importance of applying Good Engineering Practice in the preparation of design specifications, conducting design qualification, and correctly establishing contractor responsibilities for adherence to these specifications during construction and installation. The course will show the relationship of all the steps in commissioning to the project life cycle. Necessary elements will be explored in detail to assure a successful integrated commissioning qualification effort. Examples will be used to provide guidance for development of sound commissioning and validation programs resulting in reduction of cost and time of 10%-20%.
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