Annex 1 in Force! Join the First Discussion after the 25 August Effective Date

What Will Be Most Valuable to Attendees?

The recent Annex 1 and discussions leading to this update in regulation have brought about a significant change that punctuates the landscape of pharmaceutical engineering, and it plays out in equipment and how drug product manufacturers are taking steps to achieve product quality. The 2023 ISPE Pharma 4.0™ and Annex 1 Conference promises to offer a wealth of knowledge sharing, bringing together industry experts to discuss their insights and experiences. This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Annex 1 clearly focuses on the Contamination Control Strategy (CCS) and the risk of manual operations and material transfers. As shown in the pictures, barrier systems such as RABS or Isolators, Material Airlock, E-Beam, and RTPs (Rapid Transfer Ports) are seen as technical solutions.

As shown in the pictures, automation as in Pharma 4.0™ is mentioned in Annex 1 Chapter 2 Principals using robotics to reduce manual operations.

Join us and these distinguished speakers who will address the following topics:

Session 1: Regulatory Perspective on Annex 1 - Navigating the Regulatory Maze

• Speaker: WHO Regulator
• Enjoy an insider's look into the regulatory perspective on WHO Annex 2 for the manufacturing of sterile products. The presentation will cover the regulatory perspective on WHO Annex 2, assessing the comparison between the EU and PICS Annex 1 with feedback on the WHO changes. Additionally, it will touch on how the WHO Annex 2 is accepted by the industry after one year of publication and possible feedback from the industry.

Session 2: Aseptic Fill Finish of Soft Mist Inhaler: Project Experiences - Bridging Theory and Practice

• Speaker: Amanda Gilabert, Focused Factory Respimat Manager at Boehringer Ingelheim España, S.A.
• Amanda Gilabert, a seasoned professional with over a decade in the industry, brings real-world experiences to the forefront in her discussion on the Aseptic Fill Finish of Soft Mist Inhaler. Leveraging her background managing the Respimat soft mist inhaler production, Gilabert will share the challenges and opportunities faced during project implementation in the background of expected and implemented Annex 1. From project organization, transfer to design freeze, and knowledge management, attendees can expect a comprehensive view of successful project execution. Moreover, Gilabert's insights into balancing cost and quality standards will be invaluable to industry professionals striving for excellence.

Session 3: Unique BFPC for Real-time Viable Air Monitoring - A Leap Towards Future Monitoring

• Speaker: Dr. Svetlana Kiseleva, Director of Applications, Sales, and Marketing at Plair SA
• Dr. Svetlana Kiseleva, a leader in fluorescence spectroscopy and real-time viable air monitoring, will introduce attendees to a recent innovation that is becoming part of some groups’ equipment design and customer CCS. Her presentation on the Unique bio-fluorescent particle counter (BFPC) will showcase innovation in equipment for continuous environmental monitoring and microbial identification. By marrying real-time microbial monitoring (RMM) with traditional agar sampling, this unique instrument is set to be the next step in environmental monitoring practices. Dr. Kiseleva's session will explore the implementation, validation, and broader applicability of this technology, offering attendees a glimpse into the future of pharmaceutical process monitoring in order to achieve RMM, a topic that is central to many Annex 1 discussions.

Session 4: A USA Perspective of the Regulatory Landscape - Navigating the Complex Regulatory Web

• Speaker: Ryan Waldhardt, Senior Manager of Manufacturing Science and Technology, Grand River Aseptic Manufacturing
• Understanding the regulatory landscape from different perspectives is crucial in a rapidly globalising pharmaceutical industry. Ryan Waldhardt brings his extensive experience at Grand River Aseptic Manufacturing to discuss the USA Perspective of the current regulatory framework. This session promises an insightful exploration of critical topics such as EU Annex 1 Medicinal Products Rev 4, FDA CGMP 2004, and ISPE Sterile Products 3rd Edition Baseline Guide. Attendees will gain a comprehensive view of the synergies, gaps, and any discrepancies in regulations, as well as insights into how USA-based CMOs navigate the process of contract manufacturing products for the global market.

Session 5: Multi Product Aseptic Filling and the automated Loading and Unloading for the Lyophilisation

• Speakers: Patrick Wieland, Key Account Manager at Bausch and Stroebel, and Richard Denk, Senior Consultant Aseptic Processing and Containment at SKAN AG
• Since the first draft publication of Annex 1 in 2017, the topic of Barriers, Aseptic Processing as filling of sterile containers such as vials, syringes, etc., and their design modularity and transfers in and out of the barrier, as well as the loading and unloading of the Lyophilisation Process, are important features for a holistic CCS. During their presentation, the speakers will cover these topics and discuss the challenges faced by industry.

Session 6: Panel Discussion

• The track will conclude with a panel discussion where presenters will have a candid discussion on what will happen going forward, identify places where innovation hopefully will occur, and understand what possible future regulatory adjustments may occur.

On behalf of the programme committee, we personally invite you to join us in Barcelona for the 2023 ISPE Pharma 4.0™ and Annex 1 Conference and to attend this track to learn about the regulatory and industry perspective on Annex 1. We are looking forward to an impactful and interactive conference with you.

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