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global compliance panel, Online Training Webinar
2011-09-27
Why you should attend: We've all seen headlines about so-&-so company having to recall such-&-such product due to safety concerns. The worst of these stories detail injury and death of patients. In many of these situations, product contamination is at the center of the issue. Contamination of medical products, whether they are devices, drugs, or diagnostics, can be controlled and eliminated based upon sound cleaning validation studies. These studies can often be complex and intimidating. Yet, with experience and careful design, effective cleaning validation can protect patients and ensure your company's compliance with regulatory expectations.
Areas Covered in the Session:- What are FDA Requirements and Industry Standard Practices
- What are the steps to follow?
- What preparatory work is needed before starting validation?
- What are documentation requirements?
- Cleaning Validation Maintenance – How to remain under a validated status
Who Will Benefit:- QA managers and personnel
- Regulatory affairs
- Operations managers
- Engineers
- Validation professionals
- Training departments
- Consultants
- Quality Engineers
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Organized by:
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global compliance panel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2011-09-27
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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