Validation

1. The Validation unit of the NBC2 global biomanufacturing curriculum provides curricular materials to validated systems in pharmaceutical production and skill standards for training validation technicians.
2.  
3. TEXTBOOK CHAPTER
4. Chapter 4: Validation
5. Engineering Unit Overview
6.  
7. SOPs and forms

8. Autoclave Validation and Operation

9. ⇰ Operation of Harvey Sterilemax Autoclave SOP

10. ⇰ Operational Qualification for Autoclave SOP
11. ⇰ Tuttnauer 3850 ELV Autoclave Operation SOP

1.   - Autoclave Monitoring Form
2.   - Example IQ Autoclave Protocol
3.   - Example OQ Autoclave Protocol
4.  

• Filter Integrity Testing Protocol 

⇰ Filter Integrity Testing Protocol SOP

1. Activity

1. ⇰ Validation Active Learning Lab Activity
2.  
3. Skill Standards
4. ⇰ Validation Skill Standards
5.  
6. Presentations
7. ⇰ Validation by Dr. Lara Dowland
8.  
9. Other Resources:

1. VIRTUAL LABS
2. ⇰ Deliberate Documentation
3. ⇰ Good Manufacturing Practices Interactive Module
4. ⇰ Validation Fundamentals
5. By NC BioNetwork

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2. Introduction to Biomanufacturing Master Glossary
3.