Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).

• 1. Introduction to pharmaceutical microbiology2. Microbiology and pharmaceuticals3. GMP and regulations4. Laboratory management and design5. Microbiological culture media6. Microbiology laboratory techniques7. Bioburden determination8. Specified and objectionable microorganisms9. Microbial identification10. Assessment of pharmaceutical water systems11. Endotoxin and pyrogen testing12. Sterilization and sterility assurance13. Biological and enzymatic indicators: Measuring sterilization14. Maintaining sterility: Container closure integrity15. Antibiotics and preservatives16. Cleaning and disinfection17. Cleanrooms and environmental monitoring18. Particle counting: Conventional and spectrophotometric19. Biocontamination control strategies20. Rapid microbiological methods21. Risk assessment and microbiology22. Manufacturing and validation23. Beneficial uses of microorganisms: Biofermentation and beyond24. Cell culture, mycoplasma, and virus testing25. Microbiological data