Ekaterina Shakh

Ekaterina Shakh

Research and Industry Group Manager Russia, other CIS, Israel Beckman Coulter Life Sciences


Time and date Venue Topic Speakers

Thursday 21/11/2019

From 15:45 To 16:15

11/21/2019 15:45 11/21/2019 16:15 21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.
Conference Hall L, Hall 7, Pavillion 2

Conference Hall L, Hall 7, Pavillion 2

"21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical"

Ekaterina Shakh
Time and date

Thursday 21/11/2019

From 15:45 To 16:15

11/21/2019 15:45 11/21/2019 16:15 21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.
Conference Hall L, Hall 7, Pavillion 2
Venue

Conference Hall L, Hall 7, Pavillion 2

Topic
Speakers