Participants To Interact Online With US FDA In Process Validation Webinar

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  IT / Internet / E-mail
Article Date: 08 Jan 2009 - 2:00 PDT

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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.

The process Validation Webinar is part of ISPE's Online Learning series. "Learners who once sought to interact face-to-face with presenters may no longer have this option due to budget cuts for travel and other financial constraints, " said ISPE President and CEO Robert P. Best. "We wanted to reach the widest audience possible with this important industry information and we knew that the Internet would be the best way to do that."

Go to http://www.ispe.org/cs/webcasts/process_validation for details and online registration. Other Online Learning opportunities include Good Manufacturing Practices (GMP) webinars, Certified Pharmaceutical Industry Professional (CPIP) preparation webinars, and live recordings of education sessions. For more information about ISPE's Online Learning Program and current course offerings, please visit http://www.ISPE.org/onlinelearning.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit http://www.ISPE.org for additional Society news and information.

Source
Marni Schribman
Communications Manager
ISPE
http://www.ISPE.org