APR Nov/Dec 2022 - 10

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INSIDER INSIGHT
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The Fractured Landscape for Pharmaceutical
Manufacturing Education
How a fractured training and upskilling landscape feeds
continuing pharma quality and compliance issues
Michael I. Levitt
Vice President, Strategic Operations
Quality Executive Partners
If you are like me, you receive a dozen or more invitations to webinars,
seminars, and conferences every day. Each invitation promises to
provide insight into a host of critical issues impeding success in the
world of pharmaceutical/biotech development and manufacturing.
A colleague recently pointed out that despite the overwhelming
number of offerings, cleaning validation 483 observations from the
FDA, (these indicate practices that may compromise cleanliness or
result in microbial or chemical contamination), increased almost
70% in the last ten years over the previous decade. And while we
can debate the causes; this apparent performance decline is not an
isolated problem.
We belong to an industry focused on the health and wellness of
people. It is imperative that we challenge ourselves to get to the root
cause of what is impeding our ability to execute regulations which
were put in place to ensure safe and effective product manufacturing.
Why has industry performance declined over the last two decades?
Regulatory Oversight and
Enforcement is Not the Solution
Despite the best efforts of global regulators, over the last 110 years,
the process of achieving quality compliance by enforcement action
has not been successful.
The rapidly changing dynamics of our industry mirrors a revolution
in the development of miraculous products in biopharmaceuticals,
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| November/December 2022
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
