DAY TWO | WEDNESDAY, SEPTEMBER 25
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
Austin Little, Life Sciences Industry Consultant
SIEMENS INDUSTRY, INC.
9:00 CASE STUDY: IDENTIFYING FUTURE CHANGE CONTROL PROCESSES FOR BETTER EFFICIENCY
As automation is being implemented into manufacturing sites, changes may be slow to implement within the organization, as the workforce may be reluctant and need to be adapt and adopt behavior to align with these updates. Change control procedures have to be approached as a method for standardization, and any changes within production and processes can be controlled, recorded, and reviewed. As some manufacturing changes may require regulatory filings and prior regulatory approval, local procedures should have controls in place for these circumstances.
- Paradigms and drivers required to make major work place shifts
- Worker engagement & training strategies to leverage new technologies
- Pinpoint opportunities and implement efficiency measures
Matt Gresh, MES Base Business Lead, JANSSEN
9:45 CASE STUDY: AUTOMATION CYBERSECURITY THROUGH THE EYES OF A HACKER
From a business perspective, automation networks can reduce cost, improve quality and enable organizations to quickly adapt to changing business opportunities. But what about from a hacker’s perspective? What value do these systems provide to an attacker who gets in? More importantly, how do different design choices impact an adversary’s ability to accomplish their goals? This talk will explore the lifecycle of modern cyber-attacks, review real-world incidents, and apply those lessons to a reference architecture for manufacturing automation.
Jeff Reava, CISM, CISA, CISSP, Security Operations Lead | Information Security and Risk
10:30 COFFEE AND NETWORKING BREAK
11:00 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
MODERATOR: Austin Little, SIEMENS INDUSTRY, INC.
PANELISTS: Rey Ramos, JOHNSON & JOHNSON
Craig Adams, EDWARDS LIFESCIENCES
Surey Morales, THERMO FISHER SCIENTIFIC
12:00 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES
1:00 CONSIDERATIONS FOR IMPLEMENTING INDUSTRY 4.0 SYSTEMS WITH CURRENT PROCESSES
- Leveraging data to enhance operations and decision making
- Compilation of relevant data to increase levels of productivity and efficiency
- Updating legacy equipment to collect and utilize accurate data with new analysis
- Improve the use of data in the supply chain through digitization and tracking
Sagar Kamarthi, Professor, Mechanical and Industrial Engineering
1:45 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
Frederick Ball, Partner and Co-Lead Life Sciences and Biotech, DUANE MORRIS, LLP
2:45 END OF CONFERENCE