Validation of Bioanalytical Assays for Biologicals

This webinar will allow you to determine the ideal strategies for validation of bioanalytical assays for biologicals. You will learn the strengths and weaknesses of various techniques and determine the ideal validation pathway for your biological. It will help you develop proper validation protocols for bioanalytical assays of biologicals.

Why Should You Attend:

Biologicals are complex molecules, not only in their size, but in their uses. One needs to make sure that their biological is properly characterized so it may be able to be used as directed in a product. The variety of ways a biological can be characterized varies as well. While the various methods can give plenty of information, one needs to be able to figure out whether a validation technique is relevant to the particular needs of their biological. In order to properly validate a biological, you need to be able to choose wisely so you may be able to effectively validate the molecule.

In this seminar, you will be able to learn about the various means that can be used to validate biological, the standards that are required to validate a biological using these methods and the proper deployment of these techniques. You will also learn the advantages, disadvantages and pitfalls of the various techniques in order to most effectively use these techniques. You will also learn how properly validated assays can be used to monitor problems with your biological and to fully understand how your product may be used by end users. This will allow you to manage the production of your biological effectively and allow for a more effective quality control program to be developed for your biological, thus accelerating your organizations ability to develop and deploy products as needed by the market.

Areas Covered in the Seminar:

The webinar will include the following critical information you will need:

1. How to understand what analytical techniques your biological may need
2. What the various bioanalytical assays are along with their strengths and weaknesses
3. How to understand the pitfalls that may arise during validation of bioanalytical assays
4. How to understand the results these bioanalytical assay generate in context with your biological’s needs
5. How to monitor biological degradation and quality control issues and determine the difference between the two
6. How to properly deploy statistics to define quality standards