Articles
Found : 46
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| 1. |
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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| 2. |
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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| 3. |
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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| 4. |
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 ...
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| 5. |
A Roadmap to an Effective Cleaning Program: Validation Considerations
(Thursday, November 10, 2005 - Excerpt from Special Edition:Cleaning Validation II )
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| 6. |
A Simple Way to Establish Acceptance Criteria for Validation Studies
(Thursday, February 23, 2006 - Journal of Validation Technology)
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| 7. |
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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| 8. |
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...
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| 9. |
Computer Validation as a Team Sport: Project Management Issues
( - Journal of Validation Technology, Volume 8 Number 3 May 2002)
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| 10. |
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...
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| 11. |
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.
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| 12. |
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.
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| 13. |
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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| 14. |
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...
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| 15. |
Electronic Records and Signatures: The FDA Perspective
(Thursday, November 10, 2005 - Excerpt from Special Edition: Implementing Electronic Records and Signatures)
21 CFR Part 11: Implementing
The use of electronic records and signatures is critical to FDA-regulated industries. It enables us to apply the computer, our most powerful tool, to a much fuller advan...
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| 16. |
Environmental Monitoring Risk Assessment
(Wednesday, August 30, 2006 - Journal of GXP Compliance, January 2006, Volume 10, Number 2)
Environmental Monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth within cleanroom or controlled environments. The...
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| 17. |
Establishing a Sound IT Infrastructure in a GxP Environment (.pdf 52k)
(Friday, November 11, 2005 - )
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| 18. |
Expanding Good Recruitment Practice
( - Journal of GXP Compliance, January 2007, Volume 11, Number 2)
Patient recruitment for clinical trials is now fully recognized as one of the most significant bottlenecks to successful study completion. Most sponsor companies have either assigned internal resource...
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| 19. |
Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce Project Resources
(Tuesday, December 06, 2005 - Institute of Validation Technology)
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| 20. |
Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce Project Resources
(Thursday, February 16, 2006 - Journal of Validation Technology, Volume 8 Number 2 February 2002)
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| 21. |
Failure Modes: Simple Strategies for Improving Qualitative Quality Risk Management Exercises during Qualification, Validation, and Change Control Activities
( - Journal of Validation Technology, February 2007, Volume 13, Number 2)
The September 18, 2006 European edition of Time Magazine1 carried three interesting letters from readers on the subject of airline security and the related governmental risk control measures. Under th...
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| 22. |
FDA Conference Report: Like Finding an Old Friend (.pdf 64k)
(Friday, November 11, 2005 - )
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| 23. |
Free Articles
(Wednesday, May 24, 2006 - Institute of Validation Technology)
Institue of Validation Technology offers many free articles from past Journals. Here are just a few
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| 24. |
General Principles of Software Validation; Final Guidance for Industry and FDA Staff (pdf)
(Friday, November 11, 2005 - )
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| 25. |
GMP Assessment: A Tool To Evaluate Leadership
( - Journal of GXP Compliance, October 2006, Volume 11, Number 1)
The current audit approach is limited in its scope and ability to achieve sustainable regulatory compliance. This article describes a new approach to use Good Manufacturing Practice (GMP) assessments...
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| 26. |
Guidance for Industry: Part 11, Electronic Records: Electronic Signatures - Scope and Application (pdf)
(Friday, November 11, 2005 - )
FDA changes the scope and application of Part 11 Electronic Records and Electronic Signatures. Download the Draft Guidance for Industry: Part 11, Electronic Records: Electronic Signatures - Scope and ...
Posted By : IVTNews Manager |
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| 27. |
Implementing A Quality System
( - Excerpt from Technical Guide: Institute of Validation Technology)
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| 28. |
IVT Benchmarking
( - Institute of Validation Technology)
The Journal of Validation Technology (JVT) is pleased to introduce a new feature that promises to become a valuable resource to all involved in various types of process validation.
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| 29. |
IVT Journals 2008
( - http://www.ivthome.com/journals)
The 2008 redesign of the journals has resulted in a new layout, look, and a variety of new content that includes regular columns, increased interactivity, and expanded topics. It is a goal of the jour...
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| 30. |
IVT online resource links
(Thursday, November 10, 2005 - Institute of Validation Technology)
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| 31. |
Learning from Mistakes in Qualification and Change Control
( - Journal of Validation Technology, May 2007, Volume 13, Number 3)
Events, which are presented as scenarios or stories, can sometimes make a point more effectively than lectures on the importance of qualification. The author herein offers some scenarios that are summ...
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| 32. |
Performance Qualification of a Vial Washer
( - Journal of Validation Technology, Volume 8 Number 2 February 2002)
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| 33. |
Points To Consider In The Application Of Quality System Requirements To Medical Devices Intended For Use In Clinical Testing
( - Journal of GXP Compliance, October 2006, Volume 11, Number 1)
Not all medical devices require clinical investigation in order to demonstrate their safety and efficacy. But, even for some class II medical devices that can be cleared by the Food and Drug Administr...
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| 34. |
Points To Consider In The Application Of Quality System Requirements To Medical Devices Intended For Use In Clinical Testing
(Monday, November 13, 2006 - http://www.ivthome.com)
Some degree of clinical testing is required to demonstrate the safety and effectiveness of certain Medical Devices. In some cases, feasibility testing of a device on a limited
number of human subjec...
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| 35. |
Prerequisites for Successful Validation (.pdf 40k)
(Friday, November 11, 2005 - )
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| 36. |
Process Validation of Synthetic Chemical Processes for the Production of Active Pharmaceutical Ingredients (APIs)
(Friday, November 11, 2005 - Journal of Validation Technology, Volume 8 Number 2 January 2002)
Posted By : IVTNews Manager |
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| 37. |
Proposed Validation Standards: Computer-Related System Validation (pdf)
(Friday, November 11, 2005 - )
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| 38. |
Proposed Validation Standards: IVT Network Infrastructure Qualifications Proposed Standards (pdf)
(Friday, November 11, 2005 - )
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| 39. |
Proposed Validation Standards: Nonaseptic Pharmaceutical Processes (pdf)
(Friday, November 11, 2005 - )
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| 40. |
Remaining in a 21 CFR Part 11 Compliant State
(Wednesday, November 09, 2005 - Journal of GXP Compliance, Volume 6 Number 3 April 2002)
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| 41. |
Software Structural Testing Methods
(Thursday, November 10, 2005 - Special Edition: Computer Validation III)
Excerpt from Special Edition: Computer Validation III
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| 42. |
The 510(k) Its Purpose, Compilation, and Submission
( - )
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| 43. |
The Ken Chapman Industry Recognition Award
(Friday, August 22, 2008 - )
We invite you to nominate the individual who you feel has contributed to the Industry in the spirit of Ken Chapman. As a testament to his life-long commitment to Industry and achievement of his goals ...
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| 44. |
The Validation Lifecycle of a Biotechnology Derived Drug
( - Excerpt from Technical Guide)
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| 45. |
Validation Training: How Do You Do It?
(Wednesday, November 09, 2005 - Journal of GXP Compliance, Volume 6 Number 2 January 2002)
Pharmaceutical organizations have a training need for validation skills that cover the areas of protocol execution, protocol development, validation project management, and documentation control.
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| 46. |
Validation, Dispelling The Anathema
(Tuesday, August 29, 2006 - Journal of Validation Technology, August 2006, VOLUME 12, NUMBER 4)
Someone once asked me, “How did you become a Validation Consultant?” I had to stop and think. I began a trip down memory lane covering the last thirty years of my business career in an attempt to find...
Posted By : IVTNews Manager |
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