GMP: Good Manufacturing Practices
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Download Wednesday, June 10, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
.
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Free Trial CoursesOutline:Introduction Overview Learning objectives Who should take this course? Module overview The Starting Line Overview What is GMP? What is cGMP? World Health Organization (WHO) Why GMP? Cases From History Overview Cases from history 1930 - Lubeck - BCG Vaccine 1938 - Sulphanilamide 1940 - Contaminated Caps - Lambert 1955 - Polio Vaccine 1962 - Thalidomide Why GMP is so Important? GMP Regulations Overview GMP Regulations & Guidelines GMP's in Different Countries WHO ICH EMEA MHRA USFDA GMP concept What aspects of manufacturing does cGMP cover? Review activity Pharmaceutical Quality System (PQS) / Quality Management System (QMS) Overview What is Quality Management? Standard Operating Procedures (SOP) Quality Objective GMP as a part of Quality Assurance Requirements for an effective QA program ICH Q10 Life Cycle Phases of GMP Premises Overview Premises Production Areas Changing Rooms Storage Areas Quality Control Areas Personnel Overview Personnel General Principles Staff Product Contact Requirements Grades A,B,C & D Personal Hygiene General considerations for manufacturing areas Review activity Changes to Equipment Overview Equipment Balances Utilities Documentation Change control Qualification & Validation Overview Definitions Qualification Vs Validation Risk Assessment Types of Validation Documentation Complaints and Product Recalls Overview Complaints and product recalls Classification of defects - critical Classification of defects - major Classification of defects - minor Product recall procedures Self-Inspection Production Practices Quality Control | Objectives:Skill Level: Basic This training program has been developed to train employees with Basic Knowledge of Good Manufacturing Practices (cGMP) . | |
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