ISPE Pharma 4.0™ and Annex 1 Conference will take place in Vienna on 7 - 8 December 2022

ISPE Pharma 4.0™ and Annex 1 Conference will take place in Vienna on 7 - 8 December 2022


Pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists will meet at the 2022™ ISPE Pharma 4.0 and Annex 1 Conference to discuss the future of Pharma 4.0™ supported Aseptic Manufacturing. Recent innovations and trends in the industry will be shown and practical challenges and solutions will be discussed at the conference to be held in Vienna on 7-8 December. During the conference, there will be discussions about the impact of upcoming regulations, especially regarding Annex 1. The program will proceed interactively, and participants will have the chance to network by communicating with industry leaders, regulators and peers. 2022 ISPE Pharma 4.0™ and Annex 1 Conference can be attended in person or virtually.

The key focus themes will be:

  • Pharma 4.0™ and the Contamination Control Strategy, Environmental Monitoring, and Rapid Microbiology Testing
  • How to maximize 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

Who will speak at the event?

  • Ronald Bauer - Head of Institute Austrian Agency for Health and Food Safety (AGES)
  • Tamara Ely - Senior Policy Advisor (FDA)
  • Rico Schulze - GMDP Inspector (Landesdirektion Sachsen)
  • Mark Birse – Vice President (Technical Parexel)
  • Joydeep Ganguly – Senior Vice President (Corporate Operations Gilead Sciences Inc)

After the 2-day conference, the event will be ended on December 9 with a plant tour in companies such as Boehringer Ingelheim, Takeda and Siemens.

If you intend to attend the event, you can register on ISPE's website and find detailed subject planning of the program.

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