Articles
Found : 175
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9BASH
( - www.gxpandjvt.com)
www.gxpandjvt.com
Posted By : IVTNews Manager |
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A GCP Primer:Understanding The Basic Application Of Good Clinical Practice In The Regulated Environment For The Quality Professional
(Wednesday, August 30, 2006 - Journal of GXP Compliance, October 2005, Volume 10, Number 1)
This article provides an overview of currently accepted quality requirements for the conduct of clinical trials and is intended to serve as an introduction to that area of the regulated environment re...
Posted By : IVTNews Manager |
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A Practical Approach to PLC Validation
(Thursday, November 10, 2005 - Special Edition: Computer Validation II)
Excerpt from Special Edition: Computer Validation II
Posted By : IVTNews Manager |
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A Practical Approach to the International Conference on Harmonization Q7A GMP Guidance for Active Pharmaceutical Ingredients
(Wednesday, November 09, 2005 - Journal of GXP Compliance, Volume 6 Number 4 July 2002)
Posted By : IVTNews Manager |
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A Risk Management Solution Designed To Facilitate Risk-Based Qualification, Validation, And Change Control Activities Within GMP And Pharmaceutical Regulatory Compliance Environments In The EU
(Tuesday, August 29, 2006 - Journal of GXP Compliance, July 2006, Volume 10, Number 4)
In the European Union (EU), the Good Manufacturing Practice (GMP) requirements place specific obligations on manufacturers of medicinal products to implement risk-based qualification, validation, and ...
Posted By : IVTNews Manager |
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A Roadmap to an Effective Cleaning Program: Validation Considerations
(Thursday, November 10, 2005 - Excerpt from Special Edition:Cleaning Validation II )
Posted By : IVTNews Manager |
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A Simple Way to Establish Acceptance Criteria for Validation Studies
(Thursday, February 23, 2006 - Journal of Validation Technology)
Posted By : IVTNews Manager |
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Announcing IVT's 7th Annual Change Control Conference
(Friday, October 03, 2008 - http://www.ivthome.com/conferences)
This 3-day course is designed for developing, deploying and managing best practices in the industry. IVT's Change Control will take place on January 26-28, 2009 at the Marriott Courtyard Downtown in ...
Posted By : IVTNews Manager |
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Announcing IVT's Handling Deviations Conference
(Tuesday, November 18, 2008 - http://www.ivtconferences.com)
February 26-27, 2009 at the Hilton San Diego, Mission Bay in San Diego, CA. This informative conference brings together quality experts and regulatory representatives who will present their experience...
Posted By : IVTNews Manager |
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Application of Design of Experiment (DOE) Techniques to Process Validation in Medical Device Manufacture
(Tuesday, August 29, 2006 - Journal of Validation Technology, February 2006 Volume. 12, Number 2)
Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U....
Posted By : IVTNews Manager |
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Basic Operating Principles and Validation of Electron Beam Irradiation Systems
(Tuesday, August 29, 2006 - Journal of Validation Technology, VOLUME 12, NUMBER 1, NOVEMBER 2005)
This technical paper summarizes information compiled from a literature review on basic concepts of Electron-Beam technology: the radiation process, operating mechanisms, process control, and validatio...
Posted By : IVTNews Manager |
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BEN118
( - www.gxpandjvt.com)
www.gxpandjvt.com
Posted By : IVTNews Manager |
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Biological Industry Pocket Guide
(Thursday, September 28, 2006 - Institute of Validation Technology)
Biological products are complex entities and that is why IVT has compiled the following into a useful, portable and spiral bound pocket guide.
21 CFR PART 600 – Biological Products: General, 21 CF...
Posted By : IVTNews Manager |
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Change Control Combo SPECIAL OFFER
(Friday, February 15, 2008 - www.ivthome.com)
This offer includes a copy of: Special Edition Change Control Implementation, plus a 42 page Technical Guide: A Practical Guide to Change Control System Managememt
Posted By : IVTNews Manager |
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Computer Validation as a Team Sport: Project Management Issues
( - Journal of Validation Technology, Volume 8 Number 3 May 2002)
Posted By : IVTNews Manager |
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Computer Validation Master Planning
(Thursday, November 10, 2005 - Excerpt from Technical Guide: Computer Validation Master Planning)
The master plan should be developed early in the life cycle, with input from the targeted user community, the quality unit (regulatory/compliance), and the information technology group...
Posted By : IVTNews Manager |
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Conducting Effective Annual Product Reviews
(Wednesday, November 09, 2005 - Journal of GXP Compliance, Volume 6 Number 2 January 2002)
This article will review the regulatory requirements, benefits and purposes, and typical contents of an APR.
Posted By : IVTNews Manager |
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Conference FAQ's
( - Institute of Validation Technology)
Posted By : IVTNews Manager |
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Conference Sponsorship
( - http://www.ivthome.com)
IVT events are well known for attracting attendees from niche segments within the pharmaceutical and biopharmaceutical community. Gain a competitive advantage and reinforce your market exposure by par...
Posted By : IVTNews Manager |
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Corrective and Preventive Action: Planning to Achieve Sustainable GMP Compliance
( - Journal of GXP Compliance, Volume 6 Number 3 April 2002)
Successful implementation of Corrective And Preventive Action(CAPA) is highly dependent upon the effectiveness of the planning that goes into it.
Posted By : IVTNews Manager |
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D9BW2
( - www.gxpandjvt.com)
www.gxpandjvt.com
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D9FD1
( - www.gxpandjvt.com)
www.gxpandjvt.com
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D9FD2
( - www.gxpandjvt.com)
www.gxpandjvt.com
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D9FD3
( - www.gxpandjvt.com)
www.gxpandjvt.com
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D9LAEW
( - www.gxpandjvt.com)
www.gxpandjvt.com
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