RAPS pre-approved webinar on "Human Behavior in Cleanrooms and Controlled Environments" from GlobalCompliancePanel

Top Quote A RAPS pre-approved webinar on the topic, "Human Behavior in Cleanrooms and Controlled Environments" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider on December 11. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. End Quote
  • Fresno, CA (1888PressRelease) December 11, 2012 - Most medical products, comprising biologics, devices, drugs and diagnostics are manufactured under strictly controlled conditions in cleanrooms. To keep contaminants out of products, cleanrooms are designed, built, validated and operated to exact specifications.

    However, despite the best care, such facilities can overlook the primary source of contaminants -humans. Human care and behavior also need to strictly and consistently monitored and controlled in order to get the best results out of cleanrooms.
    This webinar helps participants understand ways by which they can identify good and bad cleanroom behaviors, retain or improve upon good ones and discard the bad ones. This training session will help them:

    o Get in-depth understanding of cleanroom contaminants
    o Achieve satisfactory inspections more easily
    o Avoid product recalls
    o Establish best personnel behavior and eliminate bad habits
    o Get higher assurance of new medical product approvals
    o Minimize non-conformances
    o Reduce personnel-related environmental contamination issues
    o Reduce rates of batch rework and rejections

    When: Tuesday, December 11, 2012 | 10:00 AM PST

    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 auditors and personnel
    o Manufacturing Operators
    o Maintenance Cleaning Personnel
    o Consultants
    o Operations managers
    o Microbiologists
    o Validation Personnel
    o Training departments

    Duration: 60 minutes
    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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