Articles
Found : 141
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| 1. |
72 downloadable Standard Operating Procedures now available
(Thursday, March 08, 2007 - Institute of Validation Technology)
The Institute of Validation Technology in association with Northwest Regulatory Support now offers 72 downloadable Standard Operating Procedures (SOP's) for current Good Manufacturing Practices (cGMP'...
Posted By : IVTNews Manager |
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| 2. |
72 downloadable Standard Operation Procedures (SOP's)
(Wednesday, October 11, 2006 - Institute of Validation Technology)
Special Offer: Purchase any 10 SOP's and receive a 10% discount. Purchase the full set and receive a 25% discount
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| 3. |
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...
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| 4. |
A Practical Approach to PLC Validation
(Thursday, November 10, 2005 - Special Edition: Computer Validation II)
Excerpt from Special Edition: Computer Validation II
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| 5. |
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)
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| 6. |
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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| 7. |
A Roadmap to an Effective Cleaning Program: Validation Considerations
(Thursday, November 10, 2005 - Excerpt from Special Edition:Cleaning Validation II )
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| 8. |
A Simple Way to Establish Acceptance Criteria for Validation Studies
(Thursday, February 23, 2006 - Journal of Validation Technology)
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| 9. |
An Approach To Human Factors Validation
(Thursday, August 17, 2006 - Journal of Validation Technology May 2006 Volume 12, Number 3)
User and use errors may be the last bastion of equipment and process safety and effectiveness problems. Human factors and ergonomics (HF&E) is fundamentally about designing, building, training, and ma...
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| 10. |
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....
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| 11. |
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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| 12. |
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...
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| 13. |
CD: Good Laboratory Practice (GLP): The Basics
(Wednesday, September 20, 2006 - Institute of Validation Technology)
New Teleseminar CD: Good Laboratory Practice (GLP): The Basics. Conducted by Gamal Amer, PhD, a recognized expert in GMP compliance and validation, presents an overview of a Good Laboratory Practices ...
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| 14. |
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
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| 15. |
Changes in the Journal-But No Change in Focus or Commitment
(Saturday, February 16, 2008 - Journal of Validation Technology)
JVT is in its 14th year of publication and has a proud history and tradition of providing valuable leading-edge information and perspectives. Major industry topics to be discussed in 2008 were likely ...
Posted By : IVTNews Manager |
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| 16. |
Cleaning Validation And Critical Cleaning Processes Event
( - www.ivthome.com/cleaningvalidation)
As one of IVT's most popular conferences, it defines a comprehensive approach to the validation of cleaning procedures for pharmaceutical and biopharmaceutical manufacturing facilities.
Posted By : IVTNews Manager |
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| 17. |
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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| 18. |
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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| 19. |
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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| 20. |
Conference Sponsorship
(Thursday, June 16, 2005 - http://www.ivthome.com)
IVT has 38 conferences planned for 2005. From Aseptic Processing to the 11th Annual Validation Week, you’re sure to find your target audience at our conferences. Having a presence at an IVT conference...
Posted By : IVTNews Manager |
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| 21. |
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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| 22. |
December 2006 Webseminar and Teleseminar CD's
(Wednesday, January 17, 2007 - IVT New Products)
If you were unable to attend one of these valuable sessions, you can now recieve this cost effective and timely training at your convenience.
Posted By : IVTNews Manager |
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| 23. |
Design and Implementation of a Forced Degradation/Chemical Stress Study with Analysis by HPLC
( - www.ivthome.com/webseminar)
WEB SEMINAR: This presentation will discuss the design and implementation of a typical forced degradation study, and how to address challenges faced during the development and validation of the HPLC m...
Posted By : IVTNews Manager |
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| 24. |
Design Process: Established Need to Final Form
(Wednesday, August 30, 2006 - Journal of GXP Compliance, October 2005 • Volume 10, Number 1)
The purpose of this article is to define a systematic design approach that can be used to streamline the design, purchase, and validation of systems used in the manufacture of Pharmaceutical, Biotechn...
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| 25. |
Developing a Cleaning Process:Cleaning in Development
(Wednesday, August 30, 2006 - Journal of GXP Compliance, April 2006, Volume 10, Number 3 )
The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understand...
Posted By : IVTNews Manager |
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