What are the most common problems with the CAPA process?
Today, frequent guest Mike Drues, president of Vascular Sciences and Jon are going to dive into that question and get you the answers you need and want.
Some of the highlights of the show include:
● Why the CAPA process is such a big issue within the industry and why Jon wrote a column on it.
● What businesses are doing instead of focusing on CAPA and why this is one of the major problems with the process, as well as why a cross-functional team is vital.
● How a management review board can help when it comes to regulations, as well as the fine line between micromanagement and giving a company too much latitude when it comes to meetings with the management review board.
● Being reactive vs. being proactive.
● Why it’s important to respect, but not fear, the FDA. Mike also talks about who you should fear when it comes to liability.
● Thoughts on whether the CAPA is used too frequently or not frequently enough.
● Thoughts on establishing criteria and giving companies the responsibility to establish that criteria themselves.
● The root cause of problems with the CAPA process and what companies can do about it.
“Does your CAPA process need a CAPA?” -Mike
“If you just focus on compliance, that makes you average.” -Jon
“Don’t think about it as a CAPA. Think about it as a PACA... The more prevention, the less correction.” -Mike
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