Why Should You Attend:
CAPA is the most cited problem in FDA 483’s nearly every year. Even short of a warning letter, inefficient and inconsistent CAPA processes are a serious drag on company operations, both time and cost. Though many companies know how to do CAPA but if it is not done efficiently and effectively and master it, it will not benefit in a sustainable way.
It is required to understand the tools and how to use it to assess strengths/weakness in your own CAPA systems, how to prioritize what to improve and how to establish meaningful CAPA system metrics.
Attend this webinar to get a comprehensive understanding how to create initial problem report, how to do effectiveness check, determine root cause, sustainable, appropriate , preemptive corrective action. Most importantly how to measure effectiveness & documentation and sustained vigilance process for continuous improvement.
Areas Covered in the Webinar:
Sources of CAPA – monitoring and responding efficiently
Assigning a CAPA – or not; best practices, risk, priority, documentation
Determining root cause – investigative techniques, pros & cons; not one size fits all
Resourcing the CAPA – ownership, time, engaging the right team, timelines
Determining appropriate corrective actions to sustainably solve the problem
The like-operations scan; preemptive action to avoid problems
Establishing and implementing an action plan; the right plan, the right people the right timing
Measure effectiveness & report - closing the loop
Documentation – critical for both internal effectiveness and audits
Sustain vigilance – watch for any recurrence or similar problems
Gather team input on learnings for continued improvement
CAPA is the most cited problem in FDA 483’s nearly every year. Even short of a warning letter, inefficient and inconsistent CAPA processes are a serious drag on company operations, both time and cost. Though many companies know how to do CAPA but if it is not done efficiently and effectively and master it, it will not benefit in a sustainable way.
It is required to understand the tools and how to use it to assess strengths/weakness in your own CAPA systems, how to prioritize what to improve and how to establish meaningful CAPA system metrics.
Attend this webinar to get a comprehensive understanding how to create initial problem report, how to do effectiveness check, determine root cause, sustainable, appropriate , preemptive corrective action. Most importantly how to measure effectiveness & documentation and sustained vigilance process for continuous improvement.
Areas Covered in the Webinar:
Sources of CAPA – monitoring and responding efficiently
Assigning a CAPA – or not; best practices, risk, priority, documentation
Determining root cause – investigative techniques, pros & cons; not one size fits all
Resourcing the CAPA – ownership, time, engaging the right team, timelines
Determining appropriate corrective actions to sustainably solve the problem
The like-operations scan; preemptive action to avoid problems
Establishing and implementing an action plan; the right plan, the right people the right timing
Measure effectiveness & report - closing the loop
Documentation – critical for both internal effectiveness and audits
Sustain vigilance – watch for any recurrence or similar problems
Gather team input on learnings for continued improvement
