DAY TWO | WEDNESDAY, SEPTEMBER 25
8:30 REGISTRATION & WELCOME COFFEE
8:55 CHAIRPERSON’S OPENING REMARKS
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 AUTOMATION AND DIGITAL DATA USE TO IMPROVE THE SPEED IN WHICH A PRODUCT GOES TO MARKET
To data scientists and process engineers, automation is a largely hidden world that can have a huge impact on the ease of data analysis and routine process monitoring. By the time automation engineers are looking to access data, they may be dealing with paper and electronic records, multiple databases, and automation systems which are already delivering and often challenging to update. Identify how the design of automation systems influence their ideal state and improve speed of delivery of products to the market.
- Using the most effective data set as a data scientist or process engineer
- Handling challenges data users face when it comes to automation design
- Designing automation with attributes that make for seamless analytics
Jacqueline Hora, Global Digital and Data Analytics Lead, ZENITH TECHNOLOGIES
10:30 COFFEE AND NETWORKING BREAK
11:00 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
11:45 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: Pamela Docherty, SIEMENS INDUSTRY, INC.
PANELISTS: Rey Ramos, JOHNSON & JOHNSON
Craig Adams, EDWARDS LIFESCIENCES
Surey Morales, THERMO FISHER SCIENTIFIC
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND 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.
Ted Douglas, Manager, Manufacturing Cybersecurity and Infrastructure Engineer | Global Information Security (GIS)
2:15 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
3:00 COFFEE AND NETWORKING BREAK
3:30 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
4:15 STREAMLINING DATA PROCESSES FOR COHESIVE FACILITY INTERPRETATION
The life sciences division is an environment where processing data is necessary to fulfill certain requirements and ensure product quality and safety. If a record is poorly documented, the data integrity can be compromised, and potentially jeopardize batch safety. Discover how the University is about to implement a cohesive data collection and interpretation plan in motion, when moving the data from one facility to another. Mitigate misinterpretation through automated procedures implemented in each facility to document data more accurately, make fewer mistakes in transferring the data across sites, and collect more data in smaller timeframe.
Tom Walker, Systems Design Specialist | Facility Automation Services, PENN STATE UNIVERSITY
5:00 END OF CONFERENCE