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Understanding Disinfectant Qualification Studies - How To Avoid Errors
This training on disinfectant qualification studies will discuss the many methods and variations used for disinfectant qualifications, the pitfalls in each method, the errors that can occur and how to identify them. It will show how you can translate the disinfectant qualification results to effective cleaning procedures and avoid FDA observations.
Why Should You Attend:
Disinfectant Qualification is an enormous undertaking for any company. If not planned and executed well; it may lead to results that can be erroneous. Learn from an expert who can share the various mistakes that can occur during this study, leading to unnecessary costs, leaving you with data that cannot be used.
This seminar will discuss all the technical details you need to know about the Disinfectant Qualification Study. The speaker will step by step walk you through the study's technical details and will advice on how to avoid errors. The speaker will also teach data review and how to evaluate log reductions. Using the nature of disinfectants how to pinpoint gross errors and technical glitches that could have occurred during execution of the study. Finally how to use the data generated by this study for routine clean room cleaning operations.
Areas Covered in the Seminar:
- Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity.
- Overview of the many methods and variations used for disinfectant qualifications.
- Tube dilution method
- Representative Hard surfaces
- Discussions on the variants of each of the methods and the benefits and shortcomings of each method.
- Discussion on the pitfalls expected when choosing each method available.
- Disinfectant Qualification Protocol Considerations.
- Planning the Study-Scheduling, costs and personnel-the first step.
- Discussion on Method Validation and how to set acceptance criteria.
- When and how Recovery Study should be performed and calculated.
- Errors that can occur during Efficacy Testing.
- How and why to verify inoculums.
- Expiry Dating Study for Disinfectants-how much to test.
- How to identify execution errors when reviewing data.
- Establishing and Implementing Corrective Actions.
- Translation of disinfectant qualification results to cleaning procedures to prevent contamination.
- Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations.
Who Will Benefit:
- Contract laboratories
- Validation personnel
Ziva Abraham, has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva has received her Master’s Degree in Microbiology and has conducted research on developing Microbial Insecticides during her graduate studies working mainly with fungi.
She has established clinical laboratory systems in Israel, and Microrite, Inc. a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, and Biotechnology Companies. Microrite focuses on helping companies with contamination control, microbiological quality control for sterile and non-sterile manufacturing, and Quality Assurance. Ziva has also developed “BACTISPELL” a microbiology spellchecker to spell check genus and species names of microbes and other microbiology related terms.
She is a member of PDA, ISPE, AAMI, and PMF and is an active mentor for graduate students at Stanford University working through the American Woman in Science Organization (AWIS). She is involved in Expanding Your Horizons a program through the Math and Scientific Network to educate young girls about careers in science. Ziva served on the editorial board of Pharmaceutical Microbiology Forum (PMF) Newsletter.
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