Process Validation: How to Collect the Right Data for Premarket Validation

Process Validation professionals know that the issue with gaining FDA approval for mass manufacture is not merely collecting data in the premarket phase, but collecting the correct data that truly demonstrates the protocols in place are valid and replicable.

Since this premarket phase (development) is crucial in flipping a pharmaceutical from development to production, highly trained process validation staff is a time- and cost-saver for biopharma companies. Our Process Validation for Drugs and Biologics course ensures that you are ready to tackle this issue and myriad others that occur in the premarket validation phase of pharmaceutical production.

Over-collecting data to ensure easy compliance with GMP regulatory inspectors is an easy trap to fall into. However, this method can trip up even an experienced data analyst when faced with a wealth of extraneous data masking the most valuable stats.

One solution to this abundance-of-caution approach is careful planning at each stage of the development, which our instructors will focus on in this two-day course, to ensure you learn how to develop rigorous protocols and reports, using modern programming and software. Most importantly, the focus will be on the correct data, and separating the wheat from the chaff in the data.

If your company is currently facing an issue in the premarket validation phase, or you are new to process validation and have specific questions on implementing pre-manufacture protocols, our instructors encourage you to prepare questions beforehand that can be answered during the course. This interactive session is designed to maximize your learning, so don’t be afraid to address your thorniest problems. Our course instructors have real-world experience and can speak to your professional concerns in a practical manner.

Visit our Training page to learn more about the Process Validation for Drugs and Biologics course.

Sources:

https://learnaboutgmp.com/good-validation-practices/the-four-types-of-process-validation/

http://www.biopharminternational.com/continued-process-verification-biopharma-manufacturing