Understanding the Regulatory Landscape
Annex 1 brings forth stringent requirements for data management, contamination control, and quality oversight in pharmaceutical manufacturing. Sessions will provide:
- Regulatory Expectations: Learn directly from regulators about their experiences with the implementation of Annex 1 related to the requirements for data management, referencing Chapter 4 and Annex 11.
- Successful Implementation Strategies: Gain insights into what constitutes a successful contamination control strategy and how to achieve data-driven manufacturing processes.
Insights from Global Pharmaceutical Leaders
The conference features industry stalwarts like AstraZeneca, Bayer, BioNTech, Boehringer Ingelheim, Johnson & Johnson Innovative Medicines, Merck Serono S.P.A., Novo Nordisk A/S, and Takeda Austria GmbH. Here's what attendees can look forward to at this year’s conference:
Designing Pharma 4.0™-Focused Manufacturing Facilities to Support Smart Manufacturing
- Interconnectivity and Future-Proofing: Learn the importance of designing facilities with interconnectivity and scalability in mind. Speakers will discuss how to approach Pharma 4.0™-focused manufacturing facility design to support smart manufacturing and accommodate future technological advancements.
Comprehensive Digital Facility Setup
- Case Studies on Digital Transformation: Gain a comprehensive overview of setting up a fully digital advanced therapy medicinal products (ATMP) facility. Topics include embracing a cloud-first strategy, integral data management, digital validation, and incremental changes with testing robots.
Global Rollout of Digital Systems
- Lessons Learned: Benefit from documented successes and challenges faced during multi-year projects. Understand real solutions for approaching global system rollouts, including site priorities, implementation processes, and harmonization efforts.
- Compliance with Annex 1: Dive into application details regarding system lifecycle, updates, and go-live milestones for global system rollouts, including hardware and digitalized system requirements to meet contamination control regulations.
Bridging Innovation and Compliance
- Pharma 4.0 Application to Annex 1: Explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing. Discuss challenges in integrating new requirements and technologies, decision-making processes for technology selection, and leveraging Pharma 4.0 concepts to ensure a lean, compliant production process within a fast-tracked project timeline.
Implementation of EU GMP Annex 1 for Critical Starting Materials
- Focus on CGT Manufacturing: Hear from manufacturers on implementing EU GMP Annex 1 requirements for critical starting materials and gene editing reagents used in Cell and Gene Therapy (CGT) manufacturing.
Greenfield Pharma 4.0 Facility Development
- Practical Approaches: Experience a practical approach to developing a vision, strategy, design, construction, and operationalizing a greenfield Pharma 4.0 manufacturing facility.
- Case Study: Delve into a case study of a continuous active pharmaceutical ingredient (API) commercialization facility currently under construction, highlighting the importance of process redesign and the necessary people change.
Why This Conference is a Must-Attend
- Regulatory Compliance and Innovation: Learn how to bridge the gap between compliance and innovation, ensuring organizations not only meet regulatory standards but also excel in efficiency and competitiveness.
- Expertise and Networking: Engage with experts who have firsthand experience in implementing complex regulations and advanced technologies. Network with peers facing similar challenges.
- Actionable Insights: Walk away with practical knowledge and strategies to implement immediately within your organization.
Who Should Attend
- Quality Assurance and Compliance Professionals: Stay ahead of regulatory changes and learn how to implement them effectively.
- Manufacturing and Operations Leaders: Discover how to integrate new technologies and processes into your operations seamlessly.
- Engineering and Facility Design Teams: Gain insights into designing facilities that are future-proof and compliant with the latest regulations.
- Data Management and IT Professionals: Understand the critical role of data in manufacturing and compliance, and how to manage it efficiently.
Don't Miss This Opportunity
The pharmaceutical industry is at a crossroads where innovation must align with compliance. This conference offers the roadmap to navigate this complex landscape successfully. By attending, attendees are investing in their organization's future, ensuring that they stay competitive while meeting all regulatory requirements.
Register today and be part of the conversation that's shaping the future of pharmaceutical manufacturing.
