About the Webinar
All pharmaceutical facilities require critical utilities to be operational. Purified Water (PW), Water for Injection, Clean Steam, Process Gases and HVAC are vital to assure the safety, quality efficacy and purity of products for patient safety.
During the webinar, Mitchell Wheeler, Senior Quality Consultant, and Sarah Harter, Senior Validation Engineer, from PharmEng Technology, Inc. will discuss best practices to help ensure critical utilities are qualified and maintained per FDA requirements, industry guidance and applicable regulations. The presentation will be followed by a Q&A session.
Critical Utilities areas to be covered: Potable Water, Purified Water and Water for Injection (WFI) ,Steam, Compressed Air, Process Gases ,Validation Life Cycle, Change Control and Risk Management ,Quality Systems - Drawings and Documents, Investigations, CAPA and Trending , Storage tanks, Welds, Piping and Rouging Maintenance, Routine System Review ,Calibration and Training ,Sanitization and Sampling ,Data Integrity, Handling and Automation ,Review of Warning Letters ,Q&A
About Presenters
Sarah Harter is a Senior Validation Engineer with PharmEng Technology with 9 years of diverse experiences as a Chemical Engineer, Senior Validation Engineer and Process Engineer. Sarah has a BS Degree in Chemical Engineering with a concentration in Biomanufacturing Sciences. With her qualifications and experience, Sarah has worked with pharmaceuticals, biologics, vaccines, engineering, and process automation areas.
Mitchell Wheeler is a Senior Quality Consultant for PharmEng Technology with 30 years of experience in operations, engineering, supply chain and quality assurance. His experiences include pharmaceuticals, biologics, combination products, medical devices, supply chain and nutritional product manufacturing. He has MS and BS Degrees in Manufacturing Technology from East Carolina and North Carolina A&T State Universities, respectively, and is certified by ASQ as a CPGP, CMQ/OE, CQA and CMDA.
12 июл 2024
