How To Conduct a Successful Process Validation
This presentation covers a methodology that can be used for any oral product process validation.
Full Process Validation consists of three parts:
Validation of process equipment installation
Validation of process equipment operation as per vendor specifications
Actual validation of the process itself.
Since most validation conducted today is performed in existing facilities - ones that have process and critical utility equipment that has already been validated - I normally give very brief mention of the first two parts and concentrate on part 3. If you have clients who will be working with a new facility or if they have newly installed equipment that has not been validated, please let me know so I can spend a bit more time on that portion of the process.
As for Process Validation, I spend time on oral liquids, compressed tablets, coated tablets, and hard gelatin capsules. I start with specific unit operations such as mixing, blending, drying, etc. and move on to following each manufacturing process through on a step-by-step basis.This is a lot to pack into a one hour presentation so I have to move through rather quickly. Once again, I can edit a presentation to meet the specific needs of a group if they tell me about their interest.
Why Should you Attend:
Learn what to do and what not to do in order to accomplish a rapid and professional process validation.
Objectives of the Presentation:
To present validation methodology and build confidence that your validation is complete and professionally formed.
Who can Benefit:
Management and Supervision of Manufacturing