Serialization is a reality - now what?
Different companies, large and small, are at varying stages of actual readiness for meeting the roll-out of regulatory requirements for serialization around the world. Experts agree serialization has a big impact on all aspects of the supply chain. Given the degree of complexity involved, it demands an understanding from the shop floor through enterprise-wide systems to mitigate risks, reduce and address defects, and ensure quality control. Serialization also has the ability to capture key supply chain data and information that can be used to maximize your investments and revolutionize the way you do business. Key issues include:
- Coordination with suppliers, CMOs, and other stakeholders
- Shop-floor tactics to prevent and address defects, and understand and define new types of defects and their critical implications
- Communication across the company and product life cycle to ensure effective data management and use for continuous supply chain improvement.
This inaugural ISPE event:
- Is led by global experts who have been working effectively on track and trace and serialization implementation issues for years
- Combines the benefits of a conference experience with valuable, interactive workshops, and peer-to-peer knowledge sharing opportunities
- Features two tracks of workshops focused on practical readiness and operationalization issues as well as more advanced topics to support companies in maximizing their assets across global supply chains
- Track A: Intermediate/Advanced:
- Benefits/Possible Risks Beyond Serialization
- Leveraging Operations to Maximize Supply Chain Performance
- Track B: Baseline/Intermediate:
- Practical Issues for Operationalizing Serialization
- Shop Floor Challenges and Beyond
- Track A: Intermediate/Advanced:
What Will I Learn?
Attendees will learn systemic approaches, essential strategies, valuable case studies, and practical “take-away” tools addressing key questions facing the pharmaceutical industry, including:
- What do you know about your data? How can you use it effectively and create true interconnectivity across the supply chain?
- What is the impact of serialization on “standard” processes on the shop floor in packaging operations, from classifying and addressing defects to sorting and repackaging?
- What are the most impactful technologies, strategies, templates, and practices for implementing a comprehensive serialization program, including providing appropriate, systemic training for all key personnel?
- What else can the data captured by serialization be used for in your network? What are the potential benefits? What are the implications for and possible unexpected expectations of having new types of aggregated data?
- What pitfalls are pharmaceutical companies experiencing as they turn on their serialization systems and begin to send serialized products through the supply chain? How can you avoid the pitfalls?
- What can we learn from the experiences of different countries to ensure successful implementation of serialization beyond compliance?
- How will the on-going, multi-year roll out of regulatory requirements worldwide impact my company and the global supply chains and stakeholders we depend on?
- As science and technology continues to rapidly evolve, what are key emerging issues, challenges, and opportunities for serialization? How can we ensure product protection and mitigate or eliminate risks to patients?
- How can we operationalize serialization effectively despite the current, complex global regulatory environment?
- How can we, as an industry, help facilitate more effective harmonization?
- How/where/when will data be shared with and from regulatory authorities, including where/when a drug has been sold, to strengthen supply chains and enable developing more effective medicines that meet patient needs?