FDA Validation 2011 - Sterile Product Assurance ? Building a Data Package that Convinces Agencies your Product is Good

This Sterile Product Assurance Webinar training will discuss the bases for the claim that your product is sterile after aseptic processing. It will demonstrate the multilayered levels of assurance that together create the assurance needed to claim sterility and how any one of them can result in regulatory issues which can cause severe effects to your position.

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.