The Institute of Validation Technology - Weekly Teleseminar Update

This teleseminar will be conducted on the telephone and is presented by Sarma Donepudi, a recognized expert in Environmental Chemistry and Biology, participants will learn how to conduct an effective Out-of-Specification investigation with purified water systems and most importantly, how to PREVENT microbial contamination. In this unique teleseminar format, lasting just one hour, Mr. Donepudi will provide you with a list of practices to follow and a step-by-step process to use. You will be able to follow along with a PowerPoint® presentation and ask questions and interact with Mr. Donepudi during the teleseminar. » Full Event Details » Can't Attend? purchase a CD from the event Participants will be provided with some common scenarios for microbial failures, so that they can interact and explore the causes of failures and corrective actions and evaluate the impact on product quality. Part I Microbial contamination in purified water systems Sources of contamination Identification and testing methods used in common microbiological labs Part II How to set up alert and action limits Evaluating FDA and EPA guidelines and establishing compliance for pharmaceutical water systems How to set up limits to meet the internal needs of your company Evaluating and implementing measures to control the limits Part III How to investigate and manage Out of Specification (OOS) results The role of QA and Water Treatment departments in monitoring limits Reviewing the microbial test results for initial and follow-up samples Classifying the microbial OOS results (Total Coliforms and Viable Microbes) Documenting through quality notification or deviation report Identifying and defining the assignable causes for microbial excursions Speciation of the organism Evaluating the impact of the deviation on product quality Implementing corrective actions Part IV Participants will be provided with exercises based on some common scenarios for purified water microbial failures, so that they can interact and explore the causes of failures, corrective actions, and evaluate the impact on product quality. Part V Mr. Donepudi will field your questions live on the phone. You will hear all questions and answers from all participants of this teleseminar. Sarma R. Donepudi Sarma R. Donepudi is the Director and Consultant for SCITECHSOLUTIONS Inc. He has several years of experience in the field of Environmental Chemistry and Biology and has twenty technical publications in the fields of environmental testing, monitoring and compliance. Sarma has spoken at various conferences and seminars on environmental health, toxicology and chemistry. He was one of the invited speakers for the recently concluded IVT Microbiology Conference. Mr. Donepudi was profiled as a role model for "Environmental Compliance Specialist" profession by the ECOCANADA career website. Sarma holds Masters degrees in Environmental Chemistry and Biology and Analytical Chemistry. Sarma has been invited to author a book on Current Environmental Issues – A South Asian perspective. He has procured multidimensional expertise in the field of QC/QA/Compliance pertaining to Pharmaceutical, Environmental and Food industries. Working in the pharmaceutical industry he gained lot of experience in testing and validating packaging components for finished drug products (solid dosages