RAPS Approved Webinar
Creating Material, Waste, and Personnel Flow Diagrams for Cleanrooms and Controlled Environments
Date & Time: Course "Creating Material, Waste, and Personnel Flow Diagrams for Cleanrooms and Controlled Environments" has been pre-approved by RAPS as eligible for up to 1.00 credits
towards a participant's RAC recertification upon full completion. Instructor Profile: Tuesday, October 16, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Charles V. Gyecsek
Price : $245.00
Charles V. Gyecsek President, MIJ Enterprises, Inc.
(for one participant)
Charles Gyecsek is formerly of Hoffman LaRoche 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 3 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.
Overview: This live webinar concentrates on identifying and discussing flow requirements associated with cleanrooms. We will explore the typical flows used in cleanrooms and controlled environments for material, waste and personnel. The webinar also discusses implementation and management of these flows based upon tried and true industry practices, guidelines, and standards. The key benefits of this course are: l
In-dept understanding of Personnel/Material/Waste Flow management.
Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections.
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Reduce product contamination issues. Avoid product recalls.
Areas Covered in the Session: l
Identify regulatory expectations regarding Personnel/Material/Waste Flow. 2012-08-14Identify “nomad” personnel and how they impact your control of flow. 2012-08-14Examine flow diagrams and procedures. 2012-08-14Identify special situations which need to be addressed in flow procedures. 2012-08-14Discuss personnel training, signs, and labels. 2012-08-14To identify SOPs and documentation.
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. ...more
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Click here to register for this webinar Who Will Benefit: l l l l l l l l
QA managers and personnel Regulatory affairs Operations managers Engineers Validation professionals Microbiologists Consultants Facility Engineers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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Overview: This live webinar concentrates on identifying and discussing flow requirements associated with cleanrooms. We will explore the ty...