Event Overview
This conference is specifically designed for gathering of pharmaceutical and biotechnology manufacturers focused on sterile drug production, aseptic processing as well as contamination control. The conference brings together senior decision-makers responsible for manufacturing, engineering, quality, validation, auditing and regulatory compliance with leading technology providers delivering the next generation of aseptic processing solutions. Designed to address the industry’s most pressing operational and regulatory challenges, the conference enables delegates to exchange best practices, benchmark manufacturing strategies, evaluate emerging technologies, and accelerate innovation across sterile drug manufacturing operations. Particular emphasis is placed on contamination control, digitalization, automation, regulatory compliance, manufacturing excellence, and the increasing complexity of biologics and advanced therapies.
Why This Event Now
In nowadays fast evolving pharmaceutical industry, sterile drug production and aseptic processing has become more critical than ever before. As sterile drug production grows in scale and complexity, the industry faces rising expectations around safety, precision, contamination control and compliance. With increasing regulatory demands and the introduction of advanced sterile drug manufacturing solutions, automation, robotics and digital technologies, aseptic processing practices are undergoing a major transformation. This conference is dedicated to addressing these challenges and shaping the future of sterile drug production and aseptic processing.
Key conference presentations:
– Sterile product manufacturing and fill-finish optimization
– Aseptic Process Simulation (APS) and media fill validation
– Validation strategies throughout the aseptic manufacturing lifecycle
– Contamination Control Strategy (CCS) implementation and optimization
– Case Study: Assessing Contamination Control Risks in Existing Life Sciences Facilities Under Annex 1
– Recombinant Cascade Reagent and Limulus Amebocyte Lysate: A Detailed Analysis of Endotoxin Testing Methods
– Training and Qualification of Personnel Involved in Aseptic Manufacturing: From GMP Compliance to Sterility Assurance
– Quality Assurance Excellence for Sterile Manufacturing: AI, Inspection Readiness and Audit Risk Management
– From Findings to Prevention: Audit Case Studies Driving Excellence in Sterile Manufacturing
– Transforming Biopharma Labs with Digital Twin and AI for Pharma 4.0 and 5.0
– Tech transfer and scale-up of sterile manufacturing processes
– Sustainability and energy efficiency within sterile manufacturing facilities
– Automated versus manual visual inspection
– Robotics, AI, and digital manufacturing in aseptic production
SPEAKERS
Michele Simone
Director, Corporate Quality Compliance, Risk Management & Continual Improvement
Bracco, Switzerland
Bruce Klopfenstein
LCV2 Project, CQV Manager
GSK, France
José Luis Toro Ph.D.
Global Head of Quality
Reig Jofre, Spain
Marta Rodríguez Vélez
Head of Corporate Quality
LETI Pharma, Spain
Shady Kamal, Ph.D.
Principal Scientist
Galderma, Sweden
Alan Kelly
Subject Matter Expert (Aseptic Fill Finish)
PM Group, Ireland
María del Mar Martí Ph.D
Global Quality Manufacturing Expert
Esteve Pharmaceutical, Spain
Darine Behloul
Responsable compliance- Sterility Assurance
Sanofi, France
Dr. Devendra Ridhurkar
Founder & CEO
RidNova Pharmaceuticals, Spain
