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RAPS pre-approved webinar on Clean room Design, Certification & Validation from GlobalCompliancePanel

Summary: GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, Clean room Design, Certification & Validation on February 7, 2013. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion. Charles Gyecsek, President of MIJ Enterpriseswill be the Speaker at this session.
This webinar offers a complete examination of designing and starting-up cleanrooms.
Because they are used in manufacturing human medical products; cleanrooms can have a deep impact on the quality of human medical products, as well as the operation of plants that manufacture them. The cost of not having proper cleanrooms is enormous: It can result in manufacturing delays, non-conformances, recalls, and regulatory action, all of which pull the business backwards. In order to avoid all these, properly designing, certifying, and validating cleanrooms and ensuring that best practices are followed is crucial.
This webinar will help participants explore the design considerations for cleanrooms. It will also offer insights on certification and validation strategies based upon tried,tested and validated industry practices, guidelines, and standards.
This webinar covers the following areas:
o Identify components and equipment and what they do
o Compare cleanroom classes.
o Identify certification requirements
o Identify validation strategies, requirements, and documentation.
These are the key benefits of this course:
o An in-depth understanding of cleanroom design
o Helping achieve satisfactory inspections more easily
o Ensuring a higher rate of approvals of new medical products
o Minimizing non-conformances
o Reducing rates of batch rework and rejections
o Reduction in product contamination issues
o Preventing product recalls
o Understanding industry standards in cleanroom certification and validation.
When:February 7, 2013,10:00 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 Q Auditors and Personnel
o Manufacturing Operators
o Maintenance Cleaning Personnel
o Operations managers
o Microbiologists
o Validation Personnel
o Training departments
o Consultants
Duration: 75 minutes
To enroll for this webinar, contact
Phone: 800-447-9407

Contact Information

  • Name: John Robinson

    Company: GlobalCompliancePanel

    Telphone: 91-800-4479407 , -

    Address: USA
    Livermore Common, Fremont,
    CA 94539, USA Phone: 1800 425 9407