Introductory Textual Materials:
The Big Picture
What is Quality? The Big Picture Introductory Text
cGMP Regulations
Regulation of the Pharmaceutical/Medical Products Industries
Access the Code
How to Access the Code of Federal Regulations
Annotated Notebook
Example of an Annotated Laboratory Notebook
Power Points:
The Big Picture
Quality: The Big (but Brief) Picture
Documentation
Documentation: The Foundation of Quality
Activities:
Case Study
Frances Kelsey and Thalidomide in the United States: A Case Study Relating to Pharmaceutical Regulations
Thalidomide
Should Thalidomide be Used for Treating Disease?
Manufacturing Practices
The FDA Website and the Good Manufacturing Practices Regulations
M&M Factory
Quality Control in the M&M Factory
Documentation Fails
When Documentation Fails
Be an Auditor
Be an Auditor: Find the Errors in This Batch Record
Laboratory Exercises:
Laboratory Notebook
Keeping a Laboratory Notebook
Writing SOPs
Writing and Following An SOP
Making a Product
Making a Product Under GMP
Putting it Altogether: Making a Product In a Regulated Environment
Diphenylamine
The Diphenylamine Assay for DNA and Method Validation
With Simulation: Contract Testing Laboratory and Biopharmaceutical Company
Quality Control
Using Spectrophotometry for Quality Control; Niacin
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