Clean Lab 2026 | IKN Italy | 26 February 2026 | TBA, Milan

CCS, Compliance and Data Integrity: with the regulatory body at Clean Lab we have charted the course for increasingly controlled environments, and guarantee safe, reliable and quality products. Over 250 industry professionals, more than 70 companies and numerous innovative suppliers. Clean Lab 2025 concluded with the presence of AIFA and FDA.

We will explore the critical issues of CCS, analyzed the benefits of paperless systems combined with Data Integrity and investigated the potential of AI as a strategic support in the training of new operators.

The experience of 30 speakers brought to life the debate on crucial topics such as:
• Integration of artificial intelligence  in cleaning validation and controlled contamination processes.
• Strategies for compliance with Annex 1 , focusing on challenges and best practices.
• Risk management  in contamination, with practical solutions shared by leading companies and AIFA.
• Data Integrity  in Digital Systems, with Concrete Examples from Kedrion and Alfasigma.
• Optimization of the Contamination Control Strategy (CCS) , with proactive analysis and improvements in Risk Assessment.
• Technological innovations  in aseptic processes, including the use of augmented reality and AI.
• Collaboration between pharma and healthcare , with ideas from IRCCS Policlinico San Matteo, Humanitas and AIFA.

Don't miss the opportunity to be part of the next discussion and join our ecosystem to stay up to date.

2025 Past Speakers

Alessia Calzolari
Ispettore Senior GMP, Ufficio Ispezione e Autorizzazioni GMP Medicinali – AIFA

Douglas Campbell
Former USFDA – Senior Consultant, InterPro QRA | USA

Lucia Ceresa
Steering Committee, PDA Italy Chapter

Andrea Pranti
Qualification Transformation Engineering Manager, GSK Vaccines

Barbara Pirola
Corporate Director, Quality Management System, Esseco Industrial

Francesco Boschi
Sr. Manager Technical Services – Global Microbiology and Aseptic Support Team (MAS), Pfizer

Gabriele Gori
Senior Quality Leader, PDA

Massimiliano Petrini
Persona Qualificata – Immuno-Gene Therapy Factory (IGTF), IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Devis Lamberti
Quality Unit Head & QP, MITIM-Recipharm

Rossella Grasselli
Sterility assurance, Recipharm

Renato Sinibaldi
Data Integrity Manager, ACS Dobfar

Anna Campanella
Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG | CH

Francesco Diroma
Sterility Assurance Lead, Thermo Fisher

Francesca Casalone
Quality Assurance Director, Bulk Production Qualified Person, ACS Dobfar

Francesca Mainza (Maienza)
Head of Corporate Quality Control, Gruppo MENARINI

Andrea Buzzigoli
QC Laboratories Supervisor, KEDRION

Francesca Merlini
CSV Manager, Gruppo MENARINI

Toni Valente
Chief Technical Officer – QP, Pierrel

Federica Aprea
Supervisor, PDS Quality Operations, Thermo Fisher Scientific

Gianluca Germani
CSV Specialist, Farmila Théa Farmaceutici

Fabio Fresi
Facility Manager, Humanitas Gradenigo

Renato Buono
QA Data Integrity Specialist, Alfasigma

Danilo Pennacchini
Sterile Academy Manager, Thermo Fisher Scientific

Luciano Ninu
Marketing Manager – Pharma Quality Control, bioMérieux Italia

Alessia Gragnato
Microbiology Tech. Expert Quality Assurance, GSK Manufacturing

Andrea Clementi
Cleanroom Product Manager, Alsco Italia

Monika Fadione (Avatar Donna)
Contamination Control Strategy Expert, BSP Pharmaceuticals

Nicolas Leliavre
Regional Application & Commercial Tactics Manager, Merck

Laura Mazza
Supervisor Microbiological Lab, Mozarc Medical