2022 ISPE Pharma 4.0™ and Annex 1 Conference
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.
New Annex 1: Are You Ready?
The 2022 ISPE Pharma 4.0™ and Annex 1 Conference is the must-attend conference to understand the revisions of the EU GMP Annex 1, Manufacture of Sterile Medicinal Products before implementation next year. Comments by ISPE and our members were included in the final document, and those stakeholders will be leading discussions and sharing important insights throughout the conference.
Gain first-hand knowledge on:
- The officially released version of Annex 1 and its interpretation
- Case studies showing how contamination control strategy is best implemented
- How retrofitting and optimisation projects are being approached (e.g., for lyophilizer loading/unloading)
- And more!
Don't miss this chance to better understand the revisions and how Pharma 4.0™ concepts can assist with implementing Annex 1.
Featured Sessions
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Regulatory Panel: Annex 1 Implementation
Global regulators will discuss the Annex 1 changes and how they impact manufacturing practices and consider how Pharma 4.0™ concepts can assist with Annex 1 implementation. View Session -
New Annex 1 Challenges for LVP Bag Manufacturing
In the new Annex 1, Large Volume Parenterals (LVP) bags require 100% Container Closure Integrity Testing (CCIT) as final product control and presents unique technical challenges. Discover how to overcome these challenges by attending this session. View Session -
Engineering Changes and Solutions Approaching the New Annex 1 in Existing Facilities
All the existing sterile manufacturing facilities will have to be compliant with the new Annex 1 requirements. This session will introduce the main requirements and propose solutions. View Session -
Annex 1 and Contamination Control Strategy Requirements for a Fully Automated Gloveless Aseptic Fill & Finish Line
Attend this session to review the requirements of the new Annex 1 focus on Quality Risk Management and Contamination Control strategy for a fully automated production site. View Session
Featured Speakers
What to Expect
Take Advantage of Vienna in December!
During this year's conference, you'll have the chance to take advantage of the stunning Christmas markets around the city of Vienna while you warm yourself with glühwein, lebkuchen, punsch, and experience the quintessential Austrian gemütlichkeit.
Learn More
Explore the Education Tracks
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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.
Key Conference Topics
- 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
Conference Highlights
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iSpeak BlogAnnex 1 of the EC GMP Guide "Manufacture of Sterile Medicinal Products" has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was... -
iSpeak BlogThe 2022 ISPE Pharma 4.0™ and Annex 1 Conference takes place in Vienna, Austria and virtually on 7-8 December, and will offer attendees several unique perspectives, case studies and site tours. This...
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.
