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Course Description
This four-hour course will highlight the main points for pharmaceutical good manufacturing practices as defined in Title 21 of the Code of Federal Regulations, Part 211, and Title 21 CFR Part 11 for Electronic Records, focusing on quality. Additionally, good documentation practices will be covered to ensure participants understand that documentation is essential for regulated industry compliance. Participants will be exposed to deficiencies noted in warning letters demonstrating non-compliant behaviors and their consequences.
Course Specifics:
- Participant Cap - 30
- Delivery - Face-to-face or Virtual
- Course Cost - $150 per hour if instructor travel is less than two (2) hours, $200 per hour if instructor travel is more than two (2) hours
- Course Length - Four (4) hours
- Printed Materials - Sent to company or college prior to delivery for them to print and disseminate
- Overnight Stays and Sustenance - Paid by company or college not to exceed $200 per day