World Conference Calendar

35105 Conferences

Sterile Product Assurance Building a Data Package that Convinces Agencies your Product is Good

Added by Referral on 2011-10-13

Conference Dates:

Start Date Start Date: 2011-12-05
Last Date Last Day: 2011-12-05

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

This webinar will provide you the foundation for building a case for the sterility assurance of your parenteral product whether clinical or commercial. It will include those elements that are defined even before you make the first batch including facility and equipment design and selection, set up and validations, qualifications and process simulations. It will help you to develop standards for your operations, how to monitor to assure you meet those standards, before, during and afterwards, and to assure that operators meet their qualification criteria.

You will also learn how other companies fail to deliver a convincing sterility assurance package to the agency. With this information you will be able to determine whether your processes and data packages are sufficient to convince the agency.
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