is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Wednesday, June 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Showing posts with label 2K Clinical Consulting. Show all posts
Showing posts with label 2K Clinical Consulting. Show all posts
Wednesday, May 11, 2011
Monday, December 6, 2010
Enhanced Monitoring Tools and Strategies to Optimize Productivity and Compliance
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Tuesday, January 11th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Monday, November 8, 2010
Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Thursday, December 9th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
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