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The New Draft FDA Guidance on Process Validation—What Does it Mean for You?

Presented at: 5th Annual PEGS Conference Boston, MA, April 10, 2009

The FDA issued new draft guidance to industry on process validation for comment in November of 2008. While not finalized, this guidance along with other “21st Century” initiatives, such as QbD, provide a road map that organizations can use now to approach their development efforts, whether in-house or outsourced. Here is a comprehensive review of these initiatives and impact to key industry players along with with practical insights that can be used for the entire product development lifecycle.

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