Another
invitation to a webinar: QbD
& PAT - The Scientist Is No Longer In The Laboratory, But Integrated In The
Overall Quality Process
And the
introduction to the invitation: The
industry is looking at more holistic approaches to improve processes of
bringing new products to market that can accelerate product development and
lower operational costs. Quality by Design (QbD) has come relatively late to
the pharmaceutical industry. In terms of quantifiable benefits, the main QbD
value comes from four main areas; (1) a reduction of Cost of Goods Sold (COGS)
and capital expense, (2) increased technical development productivity, (3)
improved quality and lower risk, and (4) increased sales.
I do not
agree with items 1, 2 and 4 – the statements are questionable. But the most
striking is the title: “The Scientist Is No Longer In The Laboratory”! I like
this approach! Who will develop novel medicinal products? RA, QA or QC staff? Eroom law works well!
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