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Introductory cGMPs Training

This course provides the cGMP training that new employees in FDA regulated facilities need as a foundation. It may be the only cGMP training that some employees need. For others it can serve as the basis for further, more job specific cGMP training. This course can also be used as an annual GMP refresher training.

Who Should Participate:	Anyone who works in operations, maintenance, laboratory, engineering, R&D, or other functions whose work affects production facilities that are covered by the FDA.
Class Length:	Normally 1.5 hours
Course Prerequisites:	None
Course Objectives:	At the conclusion of the class participants should be able to:

Define cGMPs
Explain why final product testing does not insure quality
Tell why following cGMPs is necessary
Tell why maintaining buildings and equipment is important and why problems should be reported immediately
Explain the importance of perimeter inspections
Respond appropriately during FDA inspections
Explain the necessity of mixup prevention
Tell how security, health, hygiene, and protective clothing procedures are different in FDA regulated environments
Tell what the major sources of microbial contamination are
Tell how pests bring diseases into the plant
Understand the consequences of the bacterial exponential growth curve and why dirty equipment must be cleaned as soon as possible
Explain the importance of Standard Operating Procedures and how they should be used
Tell how to respond to a deviation
Tell how to fill in records and what to do if there is an error
Explain the significance of a signature and date on a document
Understand that "If you didn't document it, you didn't do it"
Explain the importance of the individual employee's role in assuring product quality