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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
2011-08-31
Why you should attend: Validation master planning outlines the approach and rationale for a validation project, and therefore it is important to understand why and how a validation plan can benefit a validation project. This presentation will explain the benefits and also the risks involved with developing a validation master plan as a foundation document for a validation project.
Areas Covered in the Session:- Review Typical Validation Methodology
- An overview of the 'V-Model'
- FDA expectations regarding VMPs and Validation Plans (VPs)
- Who should be involved in developing a VMP?
- What is typically included in a VMP?
- What would be recommended or best practice?
- What should be avoided?
- When is a VMP necessary or preferred?
- When is a VMP required (if at all)?
- Why use a VMP instead of a VP?
- Is there any time a VMP shouldn't be used?
- What can a VMP do to help or hinder?
- Benefits of using a VMP
- Typical problems experienced with an incomplete or inadequate VMP.
- How to resolve issues if any are discovered during execution or final review
Who Will Benefit:- All levels of Management for all departments and those who desire a better understanding
- QA/QC/Compliance/Regulatory Affairs
- Engineering/Technical Services
- Consultants
- Operations and Manufacturing
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Organized by:
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global compliance panel |
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Invited Speakers:
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Elise Miner is one of QPharma's Associate Validation Managers and has worked with top 20 pharmaceutical companies in the validation and compliance industry since 2001. Elise's expertise spans computer and laboratory systems in the life science industry. She has developed and implemented global methodology for the validation of Facilities, Utilities and Equipment, including quality and supporting documentation, training, and websites for clients that have included Sanofi-Aventis, Schering-Plough, LifeCell Corporation and Sepracor, among others. She is regularly tapped to be the senior member on project teams responsible for establishing goals, developing timelines, training new hires, and ensuring compliance with current industry standards.
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Deadline for Abstracts:
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2011-08-31
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Registration:
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2011-08-31 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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