CCE Course Portfolio
If you are interested in bringing one of these courses to your company as an in-house course for training more of your employees at once, please contact us.
The majority of these courses are also publicly offered once each year predominantly in San Diego, CA.
We listen to your needs, please fill out the Course Interest Form. The more people are interested in a particular course, the earlier it will be offered again. Thanks for your interest.
U.S.
Regulation of Biologics and Biopharmaceuticals
-
FDA Policies and Expectations -
Course Director: Jeanne M. Novak, Ph.D.
The Technical Regulatory Expectations
in
Development and Manufacture of Biotherapeutics
Course Director: Frieder K. Hofmann, Ph.D.
Right, the first Time
Course Director: Frieder K. Hofmann, PhD
Quality Healthcare Products
Implementation and Maintenance
Course Director: Frieder K. Hofmann, Ph.D.
GMP
Compliance
-
Meeting the U.S. and International Regulatory Expectations
-
Course Director: Frieder K. Hofmann, Ph.D.
Bulletproof
Validation
of
Methods, Equipment, Process, Utilities and Facility
Course Directors: Frieder K. Hofmann, Ph.D.
Documentation
- Meeting the Regulatory Expectations -
Course Director: Frieder K. Hofmann, Ph.D.
Preapproval and GMP Inspections
Course Director: Frieder K. Hofmann, Ph.D.
GMP-Conforming Pilot Plants and Production Facilities
Course Director: Kim L. Nelson, Ph.D.
GMP-Supporting
Manufacturing Facilities
-
Planning - Design - Validation - Maintenance -
Course Directors: Frieder K. Hofmann, Ph.D.
Biopharmaceutical
Production Technology
-
A Cross-training Course -
Course Directors: Frieder K. Hofmann, Ph.D.
Recovery
and Purification of Biopharmaceuticals
From Lab Scale to Production Scale
Process Design,
Operation and Validation
Course Director: Frieder K. Hofmann, Ph.D.
Contaminant
Control
in
the Manufacture of Drugs and Biologics
Course Faculty: Frieder K. Hofmann, Ph.D. and Carl J. Wilson
Isolators,
Cleanrooms and Controlled Environments
-
Design, Validation, Operation -
Course Director: Anne Marie Dixon
A Practical Approach to
Course Director: Anne Marie Dixon
Pharmaceutical
Water Systems
Design,
Validation, Operation, Maintenance
Course Director: Hubert Fleming, Ph.D.
For
more information on each course, course director or the course
fee schedule,
just click
on the course title, course director name, the city or the "fees"
button.
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