DAY TWO | WEDNESDAY, SEPTEMBER 25
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
9:00 MORNING ICE BREAKER: ESTABLISHING AND MAINTAINING OPERATIONAL ACCESS CONTROL FOR AUTOMATED SYSTEMS
- Creating safeguards and baseline security requirements within operating systems
- Formal assignment and verification of access controls and monitoring responsibilities
- Procedures for tracking and monitoring access to the network and controls
- Defining rights of access, restrictions, and classification of information
9:45 DATA-CENTRIC ORGANIZATION IS A FOUNDATION FOR THE PHARMACEUTICAL INDUSTRY: IS IT A CHALLENGE OR AN OPPORTUNITY?
As the pharmaceutical operations role becomes more global – with increasing complexity in development, and more usage of contract manufacturers & suppliers – there is a creation of challenges and opportunities for optimization and improvement in quality, supply chain management, efficiency and delivery of a drug to the market. Operational data is consumed by more people, teams, systems and applications than ever before, and this expansion continues as the number of data sources increases exponentially, presenting a challenge to businesses that strive to be data-driven.
- Enable companies to extract value from all sources of data in-house & vendors
- Applying operational data correctly to resolve a diverse range of challenges
- Proven benefits to improve quality and accuracy with recording and reporting
- Data initiatives that are supported & reliant on operational data being available
Petter Mörée, Industry Principal, OSISOFT, LLC
10:30 COFFEE & NETWORKING BREAK
11:00 SMALL GROUP DISCUSSIONS: INTEGRATING BIG DATA, CLOUD COMPUTING AND ITOT INTO PROCESS STANDARDS
The life science division has seen great advances in transformative technology, with many of these innovations giving manufacturers advantages to higher production and increased productivity. Bringing innovation to plant-floor production, quality control and supply chain management will allow manufacturing sites to prioritize regulatory concerns and smart technology integration. Potential challenges surrounding the integration of new technology into existing frameworks looks towards legacy equipment and the lack of capability needed to connect to automation systems or devices.
- Decrease operative costs and increase task reliability and speed
- Enabling visibility and control of all workflows and tasks
- Providing status reports of all completed, in progress, and inbound tasks
- Performing all actions identically for reliable and higher quality results
Rey Ramos, Business Process Standardization Lead, JOHNSON & JOHNSON
11:45 CGMP COMPLIANCE: RISK BASED APPROACHES FOR AUTOMATION ADHERENCE
To keep pace with the ever-changing world of regulatory compliance, manufacturers are tasked with revolutionizing legacy control systems in order to optimize performance. Emerging technological advancements, such as data collection and analysis tools, are helping facilities make more informed data-driven decisions, while also meeting regulatory requirements. Through a risk based approach, the life sciences division can pair the approval with the CGMPs to focus attention on the control of critical manufacturing points that define quality and improve efficiency for both the FDA and the industry as a whole.
- Uphold CGMP standards via connected site compliance processes
- Assessing high risk areas within compliance through a risk assessment
- Creating regulatory alerts and actionable updates to stay ahead
- Align regulations with policies, processes and related resources
Carolyn A. Alenci, Associate, DUANE MORRIS LLP
12:30 LUNCHEON FOR ALL SPEAKER, SPONSORS & ATTENDEES
1:30 CASE STUDY: IMPACT OF AUTOMATION ON FACILITY CYBERSECURITY CONSIDERATIONS
With the rise of digitization in manufacturing, the critical infrastructure demands that systems become more interconnected and intelligent. As a result, these systems also become more vulnerable to cyber threats and manufacturers must secure availability, integrity, and confidentiality of data and functions. When developing an IT/OT strategy for real-time visibility, automation engineers will encounter both threat detection and remediation when securing the system. Hearing industry best practices on collaborating with cybersecurity teams will ensure data is stored in an effective and efficient manner.
Bob Guay, Head of Cybersecurity, BIOVERATIV *Pending Final Approval
2:30 SMALL GROUP DISCUSSIONS: ESTABLISHING PARAMETERS FOR PERFORMANCE TESTING TO VALIDATE QUALITY
Utilizing KPI’s to evaluate current performance compared to baselines helps manufacturers uphold response times, reliability, resource usage, and scalability. By implementing performance testing, parameters for achievement can be established and system functions can be quantified on the production line. Determining system specifications before going live, will help automation engineers verify and validate expected response times, all while locating bottlenecks that may cause a decline in activity. By employing these tests, system failures can be pinpointed and issues can be diagnosed in early stages, keeping production efficient and reliable.
3:15 PANEL DISCUSSION: FORECASTING AUTOMATION IN THE PHARMA INDUSTRY AND THE ROLE OF MES
With trends in the life science division continuously evolving, manufacturers are under increasing pressure to keep up with and adapt internal operations to meet changing needs. MES solutions enable manufacturers to plan, track, and analyze each additional phase, and implementing these systems will provide real-time management capabilities, electronic documentation, and seamless integration with enterprise resource planning and automation systems. MES technology is equipping manufacturers with comprehensive data to manage more concise recipes while reducing the risk of production issues, and improving product quality.
- Establishing a collaborative production management structure across the enterprise
- Future integration and process requirements for MES and automation groups
- Synchronized resources and coordinated capabilities between groups for flexibility
Pamela Docherty, Life Sciences Industry Manager, SIEMENS INDUSTRY, INC.
Rey Ramos, JOHNSON & JOHNSON
Frederick Johnson, GENENTECH, INC.
Matthew Iwema, ELI LILLY
4:00 CLOSING REMARKS & CONFERENCE CONCLUSION