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VALIDATION SEMINAR

ORION ENGINEERING now offers a four hour seminar on "The Basics of Validation".

WHICH COMPANIES CAN BENEFIT FROM THIS SEMINAR?

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Companies moving into the pharmaceutical field

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Engineering Companies

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Pharmaceutical Manufacturers

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Companies whose products now fall under the FDA

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OEM Suppliers

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Construction Companies

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Companies offering services to the pharmaceutical industry

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Food products companies planning for the future

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Equipment vendors

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Companies wishing to expand their services to include the pharmaceuticals industries

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Individuals wishing to find employment in the pharmaceutical industry

WHAT DOES THE SEMINAR OFFER?

The ORION Validation Seminars provide a basic understanding of the validation process with an emphasis on the following:

bulletThe History of FDA rules and regulations
bulletcGMP’s and how they developed
bulletThe basis of validation
bulletThe Validation Master Plan
bulletAn introduction to protocols
bulletDesign Qualification
bulletInstallation Qualifications
bulletOperation Qualification
bulletPerformance / Process Qualifications
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How validation and design must mesh

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What equipment items and systems require validation

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The History File

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Change Control

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Handouts include samples of the protocols, a History File content guideline and a source guide for reference materials

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Question and Answer session

WHO AT MY COMPANY CAN BENEFIT FROM THIS SEMINAR?

bulletQuality Manager
bulletQC Manager
bulletOperations Managers
bulletMaintenance Manager
bulletEngineering Personnel
bulletPurchasing Manager

WHAT ARE MY COSTS?

The cost per attendee is $125 with a minimum of $500, plus expenses. A maximum attendance of fifteen is preferred.

The presentation utilizes a PowerPointŇ presentation requiring a video projector, a screen [or white wall] and desks for each attendee. The computer will be provided by ORION ENGINEERING.

WHAT ARE ORION’S QUALIFICATIONS?

The Seminar presenter is W.N. "Charlie" Weaver, PE

Mr. Weaver has in excess of 40 years of industrial design and project management experience in the pharmaceutical, medical device, specialty chemicals, polymers, fibers and environmental industries. As a Project Manager, his responsibilities have included scope definition, interfacing with clients and subcontractors, coordination of validation and design activities, review and approval of drawings, IOQ and PQ protocols, operating procedures, final reports, studies, bid package preparation, cost and schedule monitoring and preparation of coordination reports.

His validation experience covers such diverse fields as mechanical heart valves and API production units. Equipment covered by his experience includes reactors, condensers, heat exchangers, cold rooms, fermentation systems, fill finish, cappers, over-sealers, depyrogenation ovens, stopper dry heat ovens, curing ovens, autoclaves, piping systems, utilities (HVAC, pure steam, WFI water, compressed air and purified gases), bottle washers, ultrasonic units, extraction processes and others.

His training seminars experience includes industrial safety and industrial fire fighting, validation for engineers and managers, WFI Water Systems, cGMP’s, basics of fermentation system design, protocol preparation and execution.

He is a registered Professional Engineer in North Carolina, Tennessee and Connecticut.

HOW DO I ARRANGE FOR A SEMINAR?

For a proposal contact ORION ENGINEERING, PLLC by:

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e-mail - Training@OrionEngr.com

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Phone - 704-523-1707

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Fax - 704-523-4435

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Mail - Suite 118, 610-B Minuet Drive, Charlotte, NC 28217

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Last modified: 12/21/04