Displaying 1–7 of 7 results for Ali Afnan, Principal, StepChange Pharma

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Can FDA Walk the Talk on Standards?

(Article)

FDA’s Office of Product Quality needs a change agent. Ali Afnan has a suggestion.

FDA, Revisit Your Sampling Guidance!

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Why are we so comfortable following draft guidance—FDA’s unfinished and incomplete current thinking?

Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the ...

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Effective change must improve business performance, and not just a process.

Afnan: Scientific Sampling

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Process knowledge demands a very different approach to sampling.

Ali Afnan: Process Validation: Can We Now Get Back to Basics?

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FDA’s new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.

Crazy Like a Fox

(Article)

New paradigms are needed if PAT’s promise is to be realized for biopharma process control.

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