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Summary:ARAPS pre-approved webinar entitled “Creating Material, Waste, and Personnel Flow Diagrams for Cleanrooms and Controlled Environments” is being organized on October 16 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider. The speaker of this webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion, is Charles V. Gyecsek, cleanroom specialist and President of MIJ Enterprises. ----------------------------------------------------------------------------------------------------------------- Description:One of the fundamentals of cleanrooms is identifying flow requirements and keeping them in place. This is a mandatory requirement of cGMP regulations because reducing the occurrence of mix-ups and contamination require defining movement and control of materials, personnel and waste. This webinar will enable participants to achieve all these. Cleanrooms and controlled environments need to meet properly define flow processes in order to satisfy regulatory requirements. These processes are part of regulatory applications and need to be established based upon product requirements. This webinar will discuss these. It will cover the following areas: o Identify regulatory expectations regarding Personnel/Material/Waste Flow o Identify “nomad” personnel and how they impact your control of flow o Examine flow diagrams and procedures o Identify special situations which need to be addressed in flow procedures o Discuss personnel training, signs, and labels o Identify SOPs and documentation. ----------------------------------------------------------------------------------------------------------------- When:October 16, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Charles Gyecsek is formerly of Hoffman LA Roche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career, Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in three separate facilities. Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses. Charles is currently President of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o QA managers and personnel o Regulatory affairs o Operations managers o Engineers o Validation professionals o Microbiologists o Consultants o Facility Engineers ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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online Training, cleanrooms environments, controlled environments, Waste Flow management, cGMP regulations,
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