Competency Based Training System
The Compliance Group, Inc. has expertise in developing
specialized training to meet your needs. Training should always follow
procedure development and we suggest our procedure, programs and guidelines
being implemented include our training system. Training is very important
to us and we have developed training presentations in many areas to audiences
from a table to an auditorium. Our training professionals are able to
assist you and our training systems can be applied to many areas: procedures
and policies, engineering, validation, analytical lab areas, and facilities
personnel. We have developed three systems to conduct training:
The agencies new requirements are not only to conduct training, but also
to give assurance of the effectiveness, and assurance that the trainee
understood the training being given. Our Competency Based Training System
is very effective in critical processes and provides all the assurance
needs with built in methodology upgrading the process after each application.
The Competency Based Training System includes a Pre-Evaluate, Lesson Guide
and Presentation, Competency Checklist, Training Records, and Post-Evaluate.
Specialized Training
We utilize industry experts and consultants that have worked and lived the
operations at many different major pharmaceutical companies. We utilize
this know-how and learned knowledge to assist you. Our field experts can
assist you specialized team training in many areas.
Examples are: Filter Compatibility and Extractable Testing, Kaye 2000
Training, Cleaning Validation and Sampling, Column Media Life Studies, Validation
of Aseptic Filling and so on.
Training Presentations
The training presentations include regulatory requirements, current industry
practices and methods of implementation. The course materials are designed
to equally develop everyone from the systems expert to the upper management.
A success in implementing a company wide computerized systems validation
policy starts with our training presentation:
Computerized Systems Validation and Compliance
Complying with FDA and EMEA requirements, including Part 11, GAMP and Annex 11.
