Anyone who produces or reviews GMP, GLP, or product development records.

This introductory course looks at the GMPs established by U.S., Canadian, European Union, and World Health Organization authorities. Shows how tragedies such as sulfanilamide and thalidomide caused the U.S. Congress and FDA to react and put in place law and regulations to protect us all as consumers. Participants will learn how to consistently and efficiently meet GMP/GLP and company requirements for documenting activities. This course is valuable for all personnel who work in manufacturing or lab areas subject to pharmaceutical regulations.

• Instructor's manual
• Electronic PowerPoint presentation
• Videotape (broadcast quality, 8 min.)
• Learner's guide
• Three learner's modules
• Supervisor's module
• Post-course performance assessment
• Implementation guide
• Suggestions for customizing course and materials