Showing posts with label culture. Show all posts
Showing posts with label culture. Show all posts

Tuesday, December 9, 2014

Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT


Read the full article: Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT:

"The problem is “cultural,” said Shah, originally from India and now head of UK-based Sigma, speaking afterwards to in-Pharmatechnologist.com.

“The classic thing in India is these guys will never say no. You will say to them, ‘I need this done,’ and they’ll say ‘Of course.’”

The result is delays and frustration from buyers, he said."

'via Blog this'

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Wednesday, June 3, 2009

FDA Audit Preparation - Audit Theory - Be Ready

This Pharma Compliance Blog post, The Role of Affect in your Culture of Compliance, resonates with me. I think in principle, the core idea about being prepared for audits, extends well beyond GMP regulated industries. The takeaway for me is, of course your paperwork needs to be in order, AND your people have to prepped from an emotional and behavioral standpoint.

Related Posts:
21 CFR Part 820 QSR Audit Checklist - Are you ready?
Free 21 CFR Part 820 QSR Audit Checklist

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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