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  1. The Validation unit of the NBC2 global biomanufacturing curriculum provides an overview of validation practices and procedures typical of the biomanufacturing industry and will examine not only current concepts and practices in the validation field, but aslo the historical events that precipitated the requirement of validated systems in pharmaceutical production.
  2.  
  3. Engineering Units
  4. The engineering units of the NBC2 global biomanufacturing curriculum introduces students to five essential engineering areas underlying production of biologics.  Under each area you will find the textbook chapter, SOPs, and related curriculum materials.
  5.   2. Facilities 
  6.   3. Metrology 
  7.   4. Validation 
  8.   5. Environmental Health and Safety 
  9.   6. Operational Excellence 
  10.  
  11. TEXTBOOK CHAPTER
  12. Chapter 4: Validation
  13.  
  14. SOPs
  15. Filter Validation SOP
  16. Operation of Harvey Sterilemax Autoclave SOP
  17. Operational Qualification for Autoclave SOP
  18. Tuttnauer 3850 ELV Autoclave Operation SOP
  19.  
  20. Forms
  21. Autoclave Monitoring Form
  22. Example IQ Autoclave Protocol
  23. Example OQ Autoclave Protocol
  1.  
  2. Activity
  3. Validation Active Learning Lab Activity
  4.  
  5. Skill Standards
  6. Validation Skill Standards
  7.  
  8. Presentations
  9. Validation by Dr. Lara Dowland
  10.  
  11. Other Resources:
  1. VIRTUAL LABS
  2. Deliberate Documentation
  3. By NC BioNetwork
  4.  
  5. Good Manufacturing Practices Interactive Module
  6. By NC BioNetwork
  7.  
  8. Validation Fundamentals
  9. By NC BioNetwork

 

 

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  2. Introduction to Biomanufacturing Master Glossary
  3.  
validation
Autoclave IQ Protocol

Example autoclave IQ protocol developed by Montgomery County Community College 

validation
Autoclave Monitoring Form

Autoclave monitoring form developed by Montgomery County Community College  

validation
Autoclave OQ Protocol

Example of an autoclave OQ protocol developed by Montgomery County Community College  

validation
Chapter 4: Validation

Chapter 4 of Introduction to Biomanufacturing 

quality assurance,validation
Deliberate Documentation

 Interactive module from BiotNetwork showing how documentation is kept and used in a regulated manufacturing environment

facilities,metrology,validation,ehs,operational excellence
Engineering Unit Overview

Engineering Unit Overview for chapters 2-6 of Introduction to Biomanufacturing

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Chapter 4 of Introduction to Biomanufacturing 
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Engineering Unit Overview for chapters 2-6 of Introduction to Biomanufacturing
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