This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.

1. Chet French Manager, Global Safety Amylin Pharmaceuticals, Inc. November 2007 Lessons Learned: cGMP Case Studies

4. cGMPs Raising the “Bar of Expectations ” Tragedies Technology Evolution The Bar of Expectations

5. cGMPs “Raising the Bar”

6. Regulations: Good or Bad ?

7. Regulations: Good or Bad ? Medical Mistakes

13. IV Bottle Contamination Case IV-Associated Septicemias 1970-1971 Week of Onset 9/26/70 3/13/71 1/23/71

14. IV Bottle Contamination Case Abbott Laboratories IV Bottle - New Cap Design 1970 Abbott Laboratories USP 5% Dextrose Saline

15. IV Bottle Contamination Case Abbott Laboratories IV Bottle - New Cap Design 1970 Elastomer Liner Old Design Metal Slip Disc Glue Plastic Disc New Design Metal Slip Disc Red Rubber Disc Gilsonite

16. IV Bottle Contamination Case Contamination Intrusion

28. Hemodialysis Filter Case Manufacturing Process PASS Filter Integrity QC Test FAIL PASS Filter Integrity Retest With PF-5070 H 2 O FAIL QC FAIL

34. Schering-Plough Proventil ® Asthma Inhaler Timeline 1998 1999 2000 2001 … Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 … Puerto Rico IRE Kenilworth NJ Puerto Rico Kenilworth NJ 190K Units 60MM Units FDA FDA AAC FDA

35. Schering-Plough Proventil ® Asthma Inhaler Deaths 1998-2000 1998 1999 2000 Recall 1 Recall 2

39. Proventil ® Asthma Inhaler Case FDA Compliance Inspectional Outcomes FDA 483 Form Establishment Inspection Report Warning Letter Consent Decree NOIR Regulatory Action Continued Operation No Regulatory Action Criminal Charges