Great podcast, thanks! I've been in process automation for a decade now but am relatively new to the pharma world. This podcast frames the purpose of qualification very well. I'd love to see another episode which covers the validation aspect. Can properties of a sequence/controller etc. be re-tuned, for yield optimisation for example, without impacting the validation of a cycle? Or is there an heuristic approach to proving a parameter of a sequence will not impact quality? Great content, cannot wait for more 👏
@@ModernBiopharmaPodcast yes definitely! The validation topic in my OP is certainly something I'm interested to hear more about. Another topic is proving data integrity from instrument to batch records for new SCADA systems, and how such a system might be qualified.
Would love to see this interview from the perspective of a senior commissioning and qualification manager. Not sure I agree with everything this subject had to say.
You guys went off the rails at 44:00. Do not agree at all withyour example that hardness is not a CQA for a softener. I get what your trying to say but if you have hardness you will not meet your parameters for DI water which you need to supply the WFI still
Great podcast, thanks! I've been in process automation for a decade now but am relatively new to the pharma world. This podcast frames the purpose of qualification very well.
I'd love to see another episode which covers the validation aspect. Can properties of a sequence/controller etc. be re-tuned, for yield optimisation for example, without impacting the validation of a cycle? Or is there an heuristic approach to proving a parameter of a sequence will not impact quality?
Great content, cannot wait for more 👏
Thanks Campbell! If you ever have any suggested topics, please let me know!
@@ModernBiopharmaPodcast yes definitely!
The validation topic in my OP is certainly something I'm interested to hear more about.
Another topic is proving data integrity from instrument to batch records for new SCADA systems, and how such a system might be qualified.
Would love to see this interview from the perspective of a senior commissioning and qualification manager. Not sure I agree with everything this subject had to say.
You guys went off the rails at 44:00. Do not agree at all withyour example that hardness is not a CQA for a softener. I get what your trying to say but if you have hardness you will not meet your parameters for DI water which you need to supply the WFI still
𝐩𝓻Ỗ𝓂Ø𝓈Ｍ