The 2022 ISPE Pharma 4.0™ and Annex 1 Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights and provide an outlook on the evolving landscape and future of Pharma 4.0™ supported Aseptic Manufacturing.
The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical chain. This platform will showcase recent innovations and trends, and directly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective. The impact of upcoming regulations, in particular for Annex 1, will be integrated throughout the conference programme and panel discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.
The key focus themes will include, but are not be limited to:
- Pharma 4.0™ and the Contamination Control Strategy, Environmental Monitoring, and Rapid Microbiology Testing
- How to maximise productivity by using closed systems and disposables
- Annex 1 implementation within GXP compliance and cost containment
- Quality 4.0 and Aseptic Processing: Predictive Data Analysis, Data Science, and Process Science
- Industry Trends and Regulators’ Expectation
- Pharma 4.0™ Roadmap for implementation
- Lighthouse projects and Automation Islands to a Corporate Approach
- Case Studies, Augmented Reality, Connected Health
- Digital Maturity, Barriers and Success Factors
- Modelling and Controlling of a Holistic Control Strategy
- Pharma 4.0™ Enabling Technologies
Explore the Education Tracks
Track 1: Annex 1 - Regulatory and Manufacturing Compliance
The updated Annex 1 will impact the manufacture of sterile products, setting new requirements for QRM (Quality Risk Management), CCS (Contamination Control Strategy), and Data Management and Compliance for Computerized Systems. In this track, we will examine all these expected changes from various stakeholders’ points of view.
Track 2: Quality 4.0 and Predictive Data Analysis, Data Science, Process Science
Discuss opportunities, limitations, and potential interference with current regulations for the use of AI and machine learning. Learn about data modeling of analytical results to enable predictive analysis.
Track 3: How to Maximise Productivity by Using Closed Systems and Disposables: Annex 1 Implementation Between GXP Compliance and Cost Containment
Learn about closed systems and disposables, and how they can support the new requirements of Annex 1.
Track 4: Pharma 4.0™ Roadmap for Implementation: From Lighthouse Projects and Automation Islands to a Corporate Approach
Learn about specific Pharma 4.0™ approaches to avoid a one-size-fits-all solution when considering how to change from automation islands to a corporate approach.
Track 5: Pharma 4.0 and the Contamination Control Strategy, Environmental Monitoring and Rapid Microbiology Testing
This track will focus on how to achieve the appropriate digital maturity for a Holistic Control Strategy (HCS) and the regulatory view on opportunities and limitations.
Track 6: Pharma 4.0™ Enabling Technologies
Learn and understand real-time monitoring as the main enabler for improved quality decisions.
Who Should Attend
- Developers, Manufacturing and Engineering professionals involved in or interested in understanding the current state of digitalisation
- Quality Assurance and Regulatory professionals
- Process and Project Engineers
- Stakeholders of the Vaccination value chain
ISPE Safety Precautions
Robust risk mitigation measures are being undertaken to instill public confidence in the safety of ISPE’s in-person events. In conjunction with the venues and vendors supporting our conference, we will follow health and safety measures issued at the time of the events by state and local authorities, with consideration of CDC guidance, to minimize the spread of COVID-19 and ensure the health and safety of our event participants.