Overview:
The concept of corrective and preventative actions (CAPA) are generally intertwined with the process of ensuring product quality in Good Manufacturing Procedures (GMP)- compliant manufacturing settings. This is because CAPA has been predominantly used to address identified errors and issues per regulatory requirements within the confines of current GMP (cGMP).
Although CAPA is primarily known for its use in manufacturing of pharmaceutical products and devices, many in the laboratory and clinical settings routinely use CAPAs to address issues that arise during the implementation and conduct of clinical trials at the local (site) and global (trial-wide) levels in clinical research.
Due their functionality in assessing and addressing errors, CAPAs can provide clinical trial teams with tools to help rectify current trial related issues while at the same time implementing proactive measures for ensuring that the issues will not occur again.
The implementation of CAPAs also helps clinical trial staff understand the importance of routine training and review of a clinical trial's quality management system (QMS) to ensure efficiency, effectiveness, and transparency in their daily practices. By creating an effective CAPA program, clinical trials may be more likely to be compliant with all protocol and regulatory requirements.
Why should you Attend: When conducting clinical trials, sites, sponsors, and contract research organizations (CROs) often find themselves in a position in which errors have been made that require changes in the way that research is conducted. Identification of these errors often induces anxiety for those that made the errors, as well as for those that are required to both address the cause of the error and implementing prevention strategies to keep the error from happening again.
Ensuring that clinical research teams understand the importance of identifying the cause of the errors, creating effective corrective and preventative action (CAPA) plans, and ensuring that all affected parties can implement them is essential to the long-term success of well conducted clinical trials.
The purpose of this webinar is to address the process of identifying the causes of errors that occur at sites, developing ways to correct the errors on multiple fronts using a CAPA, and ensuring that it is implemented effectively across the clinical trial team.
At the completion of the webinar, attendees will be able to:
Define what a CAPA is, its importance from regulatory and compliance perspectives, and how it can be an essential part of a clinical trial program's Quality Management System
Identify clinical study errors in real time and determine how they have impacted study conduct on a site-specific and global study perspective
Understand how Root Cause Analysis (RCA) can be used to help identify the reason that the error happened
Determining whether a CAPA is needed to effectively address the error and
Effectively using information obtained from root cause analysis to create a CAPA that addresses:
How to immediately correct the identified error
Ways to ensure that the errors will not happen again in the future
Implementation of training requirements for clinical staff and
Ensuring that the CAPA is effective in preventing the error it was intended to address
Areas Covered in the Session: Describe what CAPAs are,review regulatory components; discuss how they can change the quality of a trial if appropriately implemented.
Break down the process of identifying the errors that lead to CAPAs and how to determine from where they originated. This will include a quick review of Root Cause Analysis and other critical thinking measures that can be used to determine how the error happened. The attendee will also learn when to determine when a CAPA is NOT needed.
This portion of the webinar will break down the parts of the effective CAPA, including:
How to correct the initially identified error in real time
How to ensure that site staff or project staff will not do it again
Implementing training programs to ensure clinical trial staff understand how to keep the errors from happening in the future and
How to appropriately evaluate the CAPA as a part of your QMS
This section will include a few examples of how to create a CAPA. examples of situations that would not require a CAPA, as well as a couple that do have successful CAPAs or unsuccessful ones. We will talk about how to address unsuccessful CAPAs immediately following the "bad" example. This section will address how to "fix" CAPAs that are not effective, and will recap what we learned during the session.
The concept of corrective and preventative actions (CAPA) are generally intertwined with the process of ensuring product quality in Good Manufacturing Procedures (GMP)- compliant manufacturing settings. This is because CAPA has been predominantly used to address identified errors and issues per regulatory requirements within the confines of current GMP (cGMP).
Although CAPA is primarily known for its use in manufacturing of pharmaceutical products and devices, many in the laboratory and clinical settings routinely use CAPAs to address issues that arise during the implementation and conduct of clinical trials at the local (site) and global (trial-wide) levels in clinical research.
Due their functionality in assessing and addressing errors, CAPAs can provide clinical trial teams with tools to help rectify current trial related issues while at the same time implementing proactive measures for ensuring that the issues will not occur again.
The implementation of CAPAs also helps clinical trial staff understand the importance of routine training and review of a clinical trial's quality management system (QMS) to ensure efficiency, effectiveness, and transparency in their daily practices. By creating an effective CAPA program, clinical trials may be more likely to be compliant with all protocol and regulatory requirements.
Why should you Attend: When conducting clinical trials, sites, sponsors, and contract research organizations (CROs) often find themselves in a position in which errors have been made that require changes in the way that research is conducted. Identification of these errors often induces anxiety for those that made the errors, as well as for those that are required to both address the cause of the error and implementing prevention strategies to keep the error from happening again.
Ensuring that clinical research teams understand the importance of identifying the cause of the errors, creating effective corrective and preventative action (CAPA) plans, and ensuring that all affected parties can implement them is essential to the long-term success of well conducted clinical trials.
The purpose of this webinar is to address the process of identifying the causes of errors that occur at sites, developing ways to correct the errors on multiple fronts using a CAPA, and ensuring that it is implemented effectively across the clinical trial team.
At the completion of the webinar, attendees will be able to:
Define what a CAPA is, its importance from regulatory and compliance perspectives, and how it can be an essential part of a clinical trial program's Quality Management System
Identify clinical study errors in real time and determine how they have impacted study conduct on a site-specific and global study perspective
Understand how Root Cause Analysis (RCA) can be used to help identify the reason that the error happened
Determining whether a CAPA is needed to effectively address the error and
Effectively using information obtained from root cause analysis to create a CAPA that addresses:
How to immediately correct the identified error
Ways to ensure that the errors will not happen again in the future
Implementation of training requirements for clinical staff and
Ensuring that the CAPA is effective in preventing the error it was intended to address
Areas Covered in the Session: Describe what CAPAs are,review regulatory components; discuss how they can change the quality of a trial if appropriately implemented.
Break down the process of identifying the errors that lead to CAPAs and how to determine from where they originated. This will include a quick review of Root Cause Analysis and other critical thinking measures that can be used to determine how the error happened. The attendee will also learn when to determine when a CAPA is NOT needed.
This portion of the webinar will break down the parts of the effective CAPA, including:
How to correct the initially identified error in real time
How to ensure that site staff or project staff will not do it again
Implementing training programs to ensure clinical trial staff understand how to keep the errors from happening in the future and
How to appropriately evaluate the CAPA as a part of your QMS
This section will include a few examples of how to create a CAPA. examples of situations that would not require a CAPA, as well as a couple that do have successful CAPAs or unsuccessful ones. We will talk about how to address unsuccessful CAPAs immediately following the "bad" example. This section will address how to "fix" CAPAs that are not effective, and will recap what we learned during the session.
Speakers
Grace Morgan - Holmes,
Who Should Attend
- Clinical Site Monitors/Clinical Research Associates
- Study Managers at Site, CRO, and Sponsor Levels
- Regulatory Associates and Managers,Study Coordinators,CROs,Sponsors
