Simona Bertolini

home / authors / simona-bertolini

Simona Bertolini is in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Articles

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1

Francesca Speroni;Ilaria Franceschini;Maurizio Valleri;Mauro Silvestri;Matteo De Nigris ;Simona Bertolini;Luca Rizzo ;Alessia Garavaglia ;Camillo Bologna;Rosa Terribile;Stefano Pompilio;Enrico Modena;Stefano Selva;Lorenza Broccardo;Cesare Armetti;Marco Adami
October 16th 2020

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

Enhancing Process Validation for Solid Oral Dosage Forms: Part 2

Enhancing Process Validation for Solid Oral Dosage Forms: Part 2

Francesca Speroni;Ilaria Franceschini;Maurizio Valleri;Mauro Silvestri;Matteo De Nigris ;Simona Bertolini;Luca Rizzo ;Alessia Garavaglia ;Camillo Bologna;Rosa Terribile;Stefano Pompilio;Enrico Modena;Stefano Selva;Lorenza Broccardo;Cesare Armetti;Marco Adami
October 16th 2020

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 19th 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 19th 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 19th 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
Man touching a knowledge sharing concept | Image Credit: ©thodonal - stock.adobe.com
Published: November 4th 2024 | Updated: November 19th 2024
Strategies for Overcoming Common Challenges in Tech Transfer