How To Conduct a Successful Process ValidationThis 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 Quality Assurance Quality Control End
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