Program: November 12

09:00 Welcome and Introduction
Chairperson PEC
Lucia Costanzo, Senior conference Manager
SESSION I – ANNEX 1 REVISION & INSPECTION TRENDS IN STERILE MANUFACTURING
Chairperson: Gabriele Gori, VP, Head of Global Audit and Risk Management – Quality GSK Vaccines, Science
09:20 Key points identified in revision of Annex 1 Version 12 through the Targeted Consultation process via appointed commenting platforms
James Drinkwater PHSS: Pharmaceutical & Healthcare Sciences Society Head of Annex 1 Focus group
09:50 Inspections Findings in Sterile Manufacturing
Luisa Stoppa: Senior GMP inspector – GMP Inspection and Certification
Dept. – Italian Medicines Agency – AIFA
10:20

Round table & Q&A Time
Moderator: G. Gori, VP, Head of Global Audit and Risk Management – Quality – GSK Vaccines, Science, PDA Science Advisory Board member
Participants:
J. Drinkwater, PHSS
Di Morris, Clinical Auditor at AstraZeneca, former GMP Audit manager and MHRA Inspector
L. Stoppa, AIFA
L. Ceresa, PDA Italy Chapter

11:00 Coffee break & networking
SESSION II – INNOVATION TECHNOLOGIES IN STERILE MANUFACTURING CONTROLS
Chairperson: Andrea Pranti, Qualification Transformation Manager – GIO Engineering at GSK Vaccines
11:40 ANNEX1 seen from the microbiological point of view: which challenges, what changes, which solutions to use
Gilberto Dalmaso, Pharma and Medical Devices Consulting Owner at GDM Pharma Consulting
12:05 Q&A
12:10 MAT implementation: from validation to use in routine in a GMP QC Lab
Chiara Celli, Scientist – Biotech Process Applications Global Healthcare Operations – Merck RBM S.p.A.
12:35 Q&A
12:40 Lunch & networking
14:10 Sterility Test: why is the right time to implement the RMM?
Lucia Ceresa, Senior Technology and Market Development Manager Microbial Solutions, Charles River
14:35 Q&A
14:40 Total particles environmental monitoring system on the view of upcoming EU GMP Annex 1 guideline
Diego Bompadre, Sales Manager – RIGEL
15:05 Q&A
15:10 Round table
The Future in Sterile manufacturing Controls discussion with the involvement of Speakers and participants
Moderator: A. Pranti, GSK Vaccines
Participants: C. Celli, MERCK RBM
D. Bompadre, RIGEL
C. Celli, MERCK RBM
L. Ceresa, CRL
G. Dalmaso, GDM Pharma Consulting
15:40 Coffee break & networking
16:10 LECTURE: REGULATORY MISSTEPS – EMA ANNEX 1 STERILE MEDICINAL
by Jim Agalloco, Sterilization and sterile process expert, USP’s Microbiology Expert Committee member, Agalloco & Associates CEO
16:40 Q&A Session
16:55 Chairman’s closing remarks
Gabriele Gori,
VP, Head of Global Audit and Risk Management – Quality – GSK Vaccines, Science, PDA Advisory Board member
17:00 End of day one

Program: November 13

09:00 Welcome
Chairperson PEC
Lucia Costanzo, Senior conference Manager
SESSION III – PHARMA 4.0: AUTOMATION AND ADVANCED ASEPTIC MANUFACTURING TECHNOLOGIES
Chairperson: Michele Simone, Director, Corporate Quality Management, Quality Risk Management & Continual Improvement- Bracco Corporate; Co-Chair PDA Interest Group “Quality System”
09:20 Empowering an innovative, advanced aseptic robotic filling technology with no human intervention and a new environmental monitoring approach
Claudio Bechini, Managing Director – Pharma Integration
Cristina Testoni, Business Development – Pharma Integration
09:45 Q&A
09:50 Microbio Lab automation: case study of implementation from installation, validation to LIMS connection for data security
Serge Ohresser,
Sales Director Southern Europe/Asia- Rapid Micro Biosystems
10:15 Q&A
10:20 Round table
Pharma 4.0: Innovations and advanced aseptic manufacturing technologies: challenges and opportunities discussion with the involvement of Speakers and participants
Moderator: Michele Simone, Bracco Corporate
Participants: C. Bechini, C. Testoni – Pharma Integration
M. Giusti,
Eli Lilly, Advisor, Site External Network
S. Ohresser,
Rapid Micro Biosystems
Vicki Pearson,
Global Solution Architect – Life Science Schneider Electric
11:00 Coffee Break
SESSION IV – INNOVATION TECHNOLOGIES & BEST PRACTICES TO ENHANCE STERILITY ASSURANCE
Chairperson: Angela Petrigliano, Pharmaceutical Senior Consultant at Pharma D&S
11:40 Sterile Cleanrooms: Protect processes and products from operator’s contamination
Luciano Maggiore – Kimberly Clark Professional – Scientific Area Manager South Europe
12:05 Q&A
12:10 Autoclave sterilization: the selection of protection and packaging systems to a GMP compliant process

Sara Iacoponi Pharmaclean Product Specialist

12:35 Q&A
12:40 Lunch & networking
14:00 Round table
Innovation Technologies & Best Practices to enhance Sterility Assurance: sharing of experiences
Moderator: Angela Petrigliano, Pharmaceutical Senior Consultant at Pharma D&S
Participants:
S. Lancaster,
Global Compliance Manager at Novartis
L. Maggiore,
Kimberly
P. Muscas,
Sterility Assurance Sr Research Scientist Global TS.MS at Eli Lilly and Company
SESSION V – DESIGN AND IMPLEMENTATION OF THE CONTAMINATION CONTROL STRATEGY: SHARING OF EXPERIENCES
Chairperson: Fernanda Ferrazin, Life Sciences Expert, former GMP Senior Inspector AIFA
14:40 Update on PHSS Guidance’s ‘’Clarity on GMP’’ that supports Annex 1 and GMP regulations- CCS case study
James Drinkwater PHSS: Pharmaceutical & Healthcare Sciences Society Head of Annex 1 Focus group
15:10 Q&A
15:20 Round table
Contamination Control Strategies: sharing of experiences
Moderator: Fernanda Ferrazin, Life Sciences Expert, former GMP Senior Inspector AIFA
Participants: J. Drinkwater, PHSS
G. Dalmaso, GDM Pharma Consulting
A. Petrigliano, Pharma D&S
M. Simone, Bracco Corporate
15:50 Coffee break & networking
16:20 LECTURE SESSION – Changes to USP Informational Chapters on Sterilization & Sterility Assurance
by James Agalloco, Sterilization and sterile process expert, USP’s Microbiology Committee member, Agalloco & Associates CEO
16:50 Q&A
17:00 Chairman’s closing remarks
Fernanda Ferrazin
17:10 END OF THE CONGRESS

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