Training Doyens

OVERVIEW In order to solve problems every organization must know how to conduct an effective event investigation, identify root causes, and implement workable corrective action in a timely manner. An effective Corrective Action and Preventative Action (CAPA) process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily. WHY SHOULD YOU ATTEND This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of CAPA and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track. AREAS COVERED Definition of a CAPA When a corrective action and preventative action (CAPA) is needed Development of the essential pieces of a robust CAPA pl...

To reduce and prevent human errors it is essential to understand human behavior, the psychology of error and root causes for human error deviations . Our upcoming webinar discusses practical approaches and models for addressing and controlling human error in GMP related environments. The webinar covers the following key areas: ·          Root cause determination and investigations ·          Establishing the human error rate at your site ·          Implementing the human error reduction program Human Error Reduction Training LEARNING OBJECTIVES Understand the psychology of error Regulatory requirements in GMP environments for managing human performance deviations Root cause determination and investigations Root cause determination tool Establishing the human error rate at your site Implementing the human error reduction program Metrics ...

OVERVIEW While preventive action is now covered by ISO 9001:2015 clause6.1, Actions to address risks and opportunities, no change to existing CAPA processes is necessary to fulfill this requirement. These processes can also be extended to address opportunities by treating gaps between the current and desired states as "nonconformances" that the CAPA process can easily address. The CAPA process also supports numerous ISO 9001:2015 clauses that range from performance evaluation (9) to organizational knowledge (7.1.6), the latter in the form of a lessons learned data base. The hiyari hatto ("experience of almost accident situation") or error cause removal (ECR) process is meanwhile an employee-initiated CAPA process. It begins when a worker, or indeed any relevant interested party, identifies a potential safety or quality risk, but the context can be easily expanded to improvement opportunities. A formal CAPA process such as 8D is not required if the process ow...