Friday 7th February, 2014
9:00am to 6:00pm
Lecture 6: Understanding and Controlling Endotoxin
•Where does endotoxin come from?
•What are the properties of endotoxin?
•How do you get rid of it?
•How do you detect it?
•What assay controls are used?
•What are the endotoxin specs for water?
•How do you control it?
Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
•Water harmonization that has occurred
•Water Micro TM "Dis-Harmonization"
•A little about Biofilm
•Biofilm diversity in water systems
•Micro TM options and evaluation protocol
•The good and bad of Micro harmonization
•Where RMMs can fit in
Lecture 8: Microbial Enumeration Issues with High Purity Water Systems
•Microbial Enumeration Issues with High Purity Water Systems
•Biofilm enumeration issues (planktonic vs surface)
•Traditional cultivative approach issues
•Validation of your test method
•Alternative TM choices (advantages/disadvantages)
•Significance of water isolates
•Establishing Alert/Action Levels and Water Specs and defending them to FDA
Lecture 9: Water System Investigation "How-To's" and Example Case Studies
•Gathering and assessing existing data and symptoms
•Considering user opinions
•Investigation approach elements
•Recognizing red herrings/false positives
•Recognizing possible root causes
•Water system contamination case studies
•Parting kernels of water system wisdom
Lecture 10: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues
•PW, WFI, Pure Steam micro specifications?
•<1231> Starting water issues
•<1231> Misunderstood issues clarified
•<1231> Microbiological test issues clarified
•<1231> Suggested micro test method
•<1231> Micro Specifications
•<1231> Alert and Action Levels and max's
•Recent/Upcoming USP water changes
•Discrepancies between pharmacopeia's
Principal Consultant, Soli Pharma Solutions
Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.
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