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  1. The Validation chapter of our global biomanufacturing curriculum examines current concepts and practices in the validation field and the historical events that precipitated the requirement of validated systems in pharmaceutical production.
  2.  
  3. Engineering Unit
  4. The second unit of our global biomanufacturing curriculum introduces students to five essential engineering areas underlying production of biologics.  Under each area you will find our 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
  24.  
  25. Virtual Labs
  26. Deliberate Documentation
  27. By NC BioNetwork
  28.  
  29. Good Manufacturing Practices Interactive Module
  30. By NC BioNetwork
  31.  
  32. Validation Fundamentals
  33. By NC BioNetwork
  34.  
  35. Activity
  36. Validation Active Learning Lab Activity
  37.  
  38. Skill Standards
  39. Validation Skill Standards
  40.  
  41. Presentations
  42. Validation by Dr. Lara Dowland

 

 

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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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