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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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August 10, 2011 |
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global compliance panel, Online Training Webinar
2011-08-30
Why should you attend:
Effective internal quality system audits are critical to improve the quality system and to help prevent observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to an effective audit. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when planning, performing and documenting internal audits as well as dealing with regulators. It is also beneficial to all of management to learn the requirements so they are prepared as the auditee.
Areas Covered in the Session:- Introduction
- Applicable standards and Regulations
- Internal vs. External audits
- Resources
- Training
- Planning
- Audit tools
- Communication / Listening Skills
- Audit Documentation
- Follow Up / Effectiveness
Who Will Benefit:- RA Directors, Managers and Staff
- QA Directors, Managers and Staff
- Internal audit staff
- All Management Involved in Internal Audits
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Organized by:
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global compliance panel |
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Invited Speakers:
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Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÃœV SÃœD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits for notified bodies on a contract basis. He has 30 years of experience in the medical device industry. Prior to joining TÃœV he was with Becton Dickinson in their corporate offices as manager of quality systems. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.
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Deadline for Abstracts:
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2011-08-30
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Registration:
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2011-08-30 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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WWW: Kai Garlipp,
Frank S.
Zollmann.
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