Course offering number:0812-205
Course ID:
1954
Commissioning, Qualification and Validation
8-10 December 2008
Amsterdam, The Netherlands
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%.