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.

Areas Covered in the Seminar:

• Why sterility assurance is important to parenteral products and why the sterility test is just not enough.
• The linkage between and interdependencies of the various elements in building the case for a sterile product.
• The role facility, equipment, layout and adjacency play in assuring sterility.
• About the validation, process qualifications and simulations and operator training and qualification that play a crucial role in assuring sterility.
• The standards and monitoring needed, as well as the testing, that are required to assure the success of your operations.
• The way other companies fail to deliver on the agency expectations and how to avoid the pitfalls.