For the Spanish version of this training package, click here.
Do you know what can happen to a manufacturing facility and its employees if it is out of compliance with CGMP?
Companies that engage in the manufacture of pharmaceuticals, biopharmaceuticals, medical devices, and combination products must follow CGMP not only in commercial factories, but also in manufacturing for clinical trials, for clinical trials themselves, and for anything else that impacts a product that goes into a patient.
CGMP extend to compounding pharmacies as well, where a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.
This training package will help you increase your awareness of CGMP and comply with 21 CFR Part 211.
This product includes the following topics:
- CGMP Basics
- Regulations and Regulatory Agencies
- Consistency of Regulations Worldwide
- Major Elements of CGMP
- Good Documentation Practices (GDP)
- Linking CGMP and Compliance
- Impact of Non-Compliance
- Responsibility for CGMP
- Training Quiz (.pdf, 2 pages)
- Editable Training Quiz (.docx, 2 pages)
- Training Quiz Answer Key (.pdf, 2 pages)
- Editable Training Quiz Answer Key (.docx, 2 pages)
- Training Presentation (.pdf, 42 slides)
- Editable Training Presentation (.pptx, 42 slides)
- Training Presentation Audio Recording (.mp4, 42 slides) Note: To download just the recording with a quiz, answer key, and attendance sheet, click here.
- Training Attendance Sheet (.pdf, 1 page)
- Editable Training Attendance Sheet (.docx, 1 page)
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