Resources for Food and Drug Administration (FDA)
Participants To Interact Online With US FDA In Process Validation Webinar
www.medicalnewstoday.com ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has announced plans to host a live webinar on 13 January that will allow participants to interact with representatives of the US FDA and discuss critical process validation guidelines. The live Process Validation webinar will be held on 13 January 2009. Grace McNally, Senior Compliance Officer for the US FDA, and Paul D'Eramo, Executive Director of Johnson & Johnson, will provide insight on the FDA's draft Process Validation Guideline, highlight major concepts contained therein, discuss how the guideline may impact industry, and help participants develop a greater understanding of the document during this 90-minute live webinar. Industry feedback will be requested on the Guidance for response directly to the FDA. D'Eramo will solicit additional comments from participants for consideration by ISPE for its official response to the FDA.
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