Mastering CAPA: A Stepwise and Sustainable System

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

Dorothy Erlanger
President, Erlanger Inc.

Dorothy Erlanger is a compliance and metrics expert whose proven process for improvement drives towards sustained compliance excellence. Combining this unique process with her scientific background and facilitation expertise, Ms Erlanger leads company teams to a fundamental shift in thinking and operations around FDA compliance. Her metrics work has been used by corporations for over 20 years and has included R&D, manufacturing/production and customer-facing issues such as complaints. Her Metrics for Excellence processes have been successfully implemented in Pharma and Medical Device companies.

Follow us :