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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 also the historical events that precipitated the requirement of validated systems in pharmaceutical production.
  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.  
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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