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Maintenance of formal, written SOPs is required to maintain compliance with Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs). In addition, an effective documentation system can improve productivity and quality of work. To be effective, documentation should be clear and concise. Luckily, writers of effective SOPs are made, not born! This course will examine factors to consider when establishing or revamping an SOP system, including organizational issues, technical issues, structure of procedures, change control, and evaluation of effectiveness. A collaborative SOP exercise is included.
Lab Hours: 2.00
Lecture Hours: 2.00
Total Contact Hours: 4.00