Training Doyens

OVERVIEW We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss the CAPA best practices so you can start off on the right foot and always be prepared for an inspection. This webinar will help you use CAPA as the important improvement tool it was meant to be. WHY SHOULD YOU ATTEND Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient corrective and preventive action procedure leads to wasted time and resources. For some companies, CAPA becomes a bureaucratic maze instead of a key improvement tool. AREAS COVERED This 90-minute webinar will focus on how to improve your CAPA process to optimize efficie...

OVERVIEW Corrective And Preventive Action Procedure (CAPA) is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fail; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Or do you stop to consider whether there's actually a deeper problem that needs your attention? If you only fix the symptoms – what you see on the surface – the problem will almost certainly happen again... which will lead you to fix it, again, and again, and again. If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. CAPA Courses WHY SHOULD YOU ATTEND A...

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...