DAY ONE | TUESDAY, SEPTEMBER 24
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 CASE STUDY: AUTOMATION USE TO ENSURE CONSISTENT BATCH AND PRODUCT QUALITY
Ensuring quality in batch recipes is a wide-spread concern in manufacturing as any issues or compromises with quality assurance can halt production of a product. Having the ability to predict the end of batch quality parameters can assist manufacturers’ with detecting faults in real-time and minimizing batch-to-batch variation. By utilizing an automation system, operators are able to detect deviations early on, uphold quality, minimize disparities, and decrease costs, while keeping a plant online and running.
Tariq Tashtoush, Assistant Professor, TEXAS A&M
9:45 SMALL GROUP DISCUSSIONS: BENEFITS OF AUTOMATION ON INVESTMENT, ROI, AND FACILITY EFFECTIVENESS
The growth of new technologies and demand for faster batch cycles has escalated the need for quality software standards. With the likes of automation, standards have been raised and speed and flexibility have been introduced into the software development lifecycle. Operators are trying to reap the benefits of automation to stay competitive and optimize testing and development processes to get more done in less time – all while keeping costs down. Through the use of automation, an increase in consistent quality and decreased costs can be seen and a more effective and efficient production line is being adopted.
Karla McCance, Sr. Manager, Business Processes, FRESENIUS-KABI
10:30 COFFEE AND NETWORKING BREAK
11:00 DIGITALIZATION FOR PERSONALIZED MEDICINE- PROVEN SOLUTIONS FOR THE PHARMA ENTERPRISE
Through advancements made by Siemens, a German biotech company, BioNtech, was able to find flexibility, faster responses and full control of the individual batches made within the manufacturing operations. By providing an advanced planning tool and an MES tool that is able to meet customer needs, discrepancies are minimized and shown in a systematic manner, allowing manufacturers to enable a faster review time and find all data in a centralized location.
- Maximize utilization of resources
- Access all data in a central location any time
- Guide & control production and data entry
- Mistakes detected and reported instantly
Todd Lybrook, Portfolio Director, SIEMENS INDUSTRY, INC.
11:45 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
Daniel Velez, Corp QA Specialist, AMGEN
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES
1:30 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
GROUP 1: Rey Ramos, JOHNSON & JOHNSON
GROUP 2: Zach Klein, KALEO, INC.
2:15 DATA-CENTRIC ORGANIZATION IS THE FOUNDATION FOR THE INDUSTRY: CHALLENGE OR 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 data sources in-house & vendors
- Applying operational data correctly to resolve diverse challenges
- Proven benefits to improve quality & accuracy with recording & reporting
- Data initiatives that are supported & reliant on operational data
Petter Moree, Industry Principal, Life Sciences, OSISOFT, LLC
3:00 COFFEE AND NETWORKING BREAK
3:30 CASE STUDY: 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.
Zach Klein, Manager, MS&T, KALEO, INC.
4:15 CASE STUDY: UTILIZING PROCESS VALIDATION TO INCREASE OVERALL DATA RELIABILITY
When managing a production line, the primary goal of an automation engineer is ensuring quality and reliability is upheld, which is why validating processes and monitoring systems is crucial. Through process validation, a root cause analysis of quality and reliability concerns can be conducted and over time, can mitigate issues on the production line. Optimizing machine capacity and resources based on real-time data can assist manufacturers and guide operators to optimize drug work flow.
Keith Haynes, Sr. Validation Engineer, ALCON
5:00 END OF DAY ONE CONFERENCE