GMP/cGMP Concepts and Applications
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Date: 16th - 18th July, 2008
Location: web seminar, USA
Summary:
Clinical, Cosmetic, Pharmaceutical, Water - Training
This three session live web curriculum will present GMP/cGMP concepts and their practical application in the pharmaceutical industry. The presentation will focus on engineering, production, QC/QA and validation aspects of the GMP/cGMP requirements.
There will also be discussion of Canadian and US regulations, including their similarities and interpretations. Opportunities for Optimization of GMP/cGMP and Pharmaceutical processes will be illustrated, with practical design concepts and examples.
Points To Be Covered:
Session 1 (September 16, 2008):
Regulatory Agencies
GMP/cGMP Guidelines
Discussion of GMP/cGMP Concepts and Application
Session 2 (September 17, 2008):
GMP/cGMP Programs
Qualification
Validation
SOP Programs
Calibration Program
Change Control
Training Program
Session 3 (September 18, 2008):
Laboratory Operation Programs
Environmental Monitoring
Stability Program
Preventative Maintenance
Document Control
Good Documentation Practices