ISPE

SEPTEMBER 8, 2023

We hear people discuss the concept of second air. We hear people discuss the concept of second air. Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER I don’t think many of us would want to subscribe to the concept of second air as appropriate. How will the FDA use Annex 1 in its final version?

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FDA Vaccines Documentation 52

ISPE

JUNE 26, 2023

Iacovelli stressed and Buendia concurred that digitization should be preceded by well-developed business cases that clearly define the purpose, target, and business value, then the “people aspects” of the change, and finally, the supporting technology. It must be people who make decisions about batch release.

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FDA 97

ISPE

FEBRUARY 16, 2023

The panellists included: Roberto Conocchia GMP Technical Lead European Medicines Agency (EMA) Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER Alan Moon Lead Senior GMDP Inspector MHRA The discussions were moderated by Mark Birse and Jean-Francois Duliere. ™ and Annex 1 Conference. ™ and Annex 1 Conference.

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Documentation FDA 52

ISPE

JUNE 27, 2023

Friedman commented that it would be extremely helpful to both industry and regulators if companies were willing to share knowledge and experiences relating to new technologies. Quality of raw materials in terms of purity and safety has been and continues to be a problem said Friedman. It all starts with management stressed Friedman.

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Communication FDA Vaccines 52

ISPE

SEPTEMBER 12, 2022

Rick Friedman. Rick Friedman. But what I am finding are some fundamental issues in the design phase where the people engaged in environmental monitoring are not part of the discussion. Rick Friedman. At least 90% of contamination (in data from industry surveys) comes from people as the direct source.

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FDA Documentation Communication 52