PDA 143.1 Designing and Presenting GXP Training Programs to Meet FDA Requirements

This live eLearning training course will take trainees step-by-step through the process of designing and presenting an effective GXP training program. Using many individual and small group exercises, the attendees will practice each skill set after it is explained and will leave with a new program well on the way to completion. Topics to be covered include reviewing past GMP training topics, conducting a needs analysis, selecting a topic tied to facility quality objectives and FDA quality requirements, brainstorming creative approaches, developing the presentation, maximizing presentation success, evaluating training effectiveness, and audit-proofing training documentation.

1. Implement a GXP training needs analysis
2. Relate potential course topics to facility quality objectives and FDA quality requirements
3. Examine creative approaches to GXP training
4. Explain the process for training program development
5. Select appropriate methods of evaluation of training effectiveness