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Science and Risk Based Approach to Commissioning, Qualification and Validation

 
  July 09, 2007  
     
 
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%.

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Please click here for speaker information.
 
Deadline for Abstracts: Not applicable
 
Registration: Please click here for registration information.
E-mail: info@cfpa.com
 
   
 
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