Sponsored by: Innerspace, Solo Containment and STERIS

Co-Chairs: Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG

James Drinkwater, Head of Aseptic Processing and Containment Special Interest Group, PHSS and Head of GMP Compliance, F Ziel GmbH

Exploring Effective Strategies and New Regulations for Compliant Pharmaceutical Manufacturing

The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.

The industry is ever changing and with the advent of innovative therapeutics taking hold, regulators and industry leaders are prompted to take proactive approaches to get treatments to patients faster.

Join us to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of aseptic processing and sterile manufacturing.

Event Hashtag: #SMiAseptic

Key Highlights Include:

• Discuss the revisions and the impact of Annex 1 on aseptic manufacturing with AstraZeneca
• Listen to a field report on the implementation of a global contamination control program with Takeda
• Explore the applications of rapid micro methods in the manufacture of sterile products with AbbVie
• Discover a Risk Based Approach to Cleaning and Disinfection with STERIS
• Delve into case studies of competence in global aseptic manufacturing with Fresenius Kabi
• Uncover the journey of Isolation Technology in a large Biotech pharmaceutical plant with Eli Lilly

 Who Should Attend?

• Validation Managers
• Senior Microbiologists
• Senior QA’s and QC’s
• Quality Control Managers
• Heads of GMP Compliance
• Quality Assurance Experts
• Technical Operations Leads
• Leaders in Sterility Assurance
• Cleanroom Managers
• Regulatory Affairs Managers
• Production Managers
• Quality Systems Managers
• Heads of Quality Compliance
• Process Leaders
• Senior Auditors
• Bioprocess Research & Development

PLUS – Post-Conference Workshop on…

Contamination Control Measures in Good Manufacturing Practice (GMP) Applied to Aseptic Processing
Workshop Leaders: James Drinkwater, Head of Aseptic Processing and Containment Special Interest Group, PHSS and Head of GMP Compliance, F Ziel GmbH Kevin Jenkins, Consultant, Quality Excellence Consulting