Course offering number:0810-203
Course ID:
1954
Commissioning, Qualification and Validation
October 7-9, 2008
Burlingame, CA
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
- Production
- Regulatory Affairs
- Quality Control/Assurance
- Technical Services/Validation
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
Good Engineering Practice (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 (GEP) 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%.