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Training |
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CBR International prides itself on the
expertise of its consultants and encourages its clients to
draw on their knowledge through customized training. We tailor
our instructional programs to ensure our clients receive the
most up to date and pertinent industry and regulatory authority
information available to both meet and exceed compliance training
requirements.
Our instructors provide both classroom style and practical
hands-on educational programs for all qualification levels.
We offer training in current Good Clinical Practice (cGCP),
Good Manufacturing Practice (cGMP), Quality Systems, Validation
Techniques, Analytical Methods, and many other regulatory
and scientific topics. Training sessions and instructional
materials are created specifically for each training session
to ensure the latest regulatory information is being presented.
Our consultants are in constant communication with members
of the regulatory agencies so your firm will be well informed
and know what to expect in an ever-changing regulatory climate.
Previous hands-on sessions have included instruction in sterile
filling techniques, cleanroom maintenance and environmental
monitoring. Classroom style training has included cGCP training
for a world renowned oncology research center and corporate-wide
introductory cGMP training for a number of biopharmaceutical
firms. Training is highly successful and effective as documented
through pre and post assessment tools. Notebook handouts and
critical reference materials are an invaluable resource for
future staff reference.
As an enhancement to your training program, we offer video
documentation of training sessions. This documentation allows
for standardized training of new employees and provides an
easy solution for refresher courses.
Our training cadre includes former FDA reviewers and investigators,
former senior scientists and quality control directors from
world-class drug manufacturing facilities as well as former
team leaders in innovative drug research groups. Our staff
holds Doctorates, Master’s degrees and Certifications
in all areas of science and regulatory affairs.
Specific Consulting and Development
Experience
Consistent, thorough and up-to-date analysis of your evolving
needs is just the beginning of our commitment to your program.
For a comprehensive assessment of your program requirements,
please contact us by calling (720) 746-1190 or by email at
info@cbrintl.com.
Current
Good Manufacturing Practice (cGMP) Training • Hands-On
Instruction • Current Good Clinical Practice (cGCP)
Training • Train-the-Trainer Programs • Validation
Techniques • In-House Presentations • Quality
Systems • Cleanroom Maintenance • Interactions
with FDA • Analytical Methods • Good Documentation
Practices • Technical Writing Techniques |
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