Discuss how Barr Labs impacted cleaning validation

Read Chapter 1-2 in the course textbook.Write a 2-3 page summary of the chapters and discuss them in the context of theWeek 1 Lecture. Discuss the origins of cleaning validation limits Discuss how Barr Labs impacted cleaning validation Discuss the influence of FDA’s 1993 guidance Discuss why the HBEL is an improvement over the previous approaches to setting limits Read Chapters 3-7 in the course textbookWrite a 2-3 page summary of the chapters and discuss them in the context of theWeek 1 Lecture. What is Risk (Hazard) Identification? Discuss how chemical hazards are identified Discuss how microbiological hazards are identified Discuss how equipment design hazards are identified Discuss how procedural hazards are identified

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