This webinar covers the central role of CAPA for the FDA, challenges in building an effective CAPA system, gives a comprehensive understanding of a CAPA process which is highly effective and sustainable, becoming a tool for continuous improvement. It will discuss capturing and assessing potential CAPA’s, using risk-based assessment, documentation, determining true root cause, how to take preemptive preventive action and using metrics for long-term improvement. The course will also discuss potential changes as FDA considers integration with ISO 13485.
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.
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
Who Will Benefit:
- Chief compliance officers
- Manufacturing directors and supervisors
- Regulatory affairs professionals
- QA management
- Quality system auditors
- Risk management specialists
Speaker
Dorothy ErlangerCourse Provider
Dorothy Erlanger,
