8:45 Chairperson’s Opening Remarks
Marlene Eeg, Director, Business Development, NYMI
9:00 CLARIFYING COMPLIANCE WITH THE FDA DATA INTEGRITY GUIDANCE
In the spring of 2016, the FDA released a draft guidance for data integrity in manufacturing data collection and archiving, including recommendations surrounding Current Good Manufacturing Processes (CGMP). The guidance underscores the importance of data that is “complete, consistent and accurate” and that provides a clear electronic trail capturing the history of a specific batch. With differing structures from one MES to another in pharmaceutical organizations, in addition to the plethora of end-users involved in manufacturing operations and controlling data, the overall level of noncompliance risk is of concern to many corporations. It is therefore pivotal for MES executives to secure a strong understanding of the FDA guidance as it relates specifically to manufacturing execution systems and applications.
- Practical application of to ensure compliance
- Compliant documentation of MES implementation
- Focus on data justifying software validation
- Data archiving & electronic audit trail
Eileen Cortes, Assoc. Dir. QA CSV, BIOMARIN
9:45 ACHIEVING ESSENTIAL DATA COLLECTION FOR ACCURATE & COMPLIANT ELECTRONIC BATCH RECORDS
When transitioning from paper-based batch records to electronic through MES implementation, professionals commonly need to redefine priorities in the type of data that must be captured to ensure compliance, versus data that is useful but not mandatory. In the instance where data is not categorized, MES executives face the burdensome task of validating a multitude of unnecessary information, which can slow down the overall MES & EBR process launch. Further, early consideration of EBR integration with other control systems within the manufacturing site is pivotal to ensure data capture capabilities in due time, ultimately enabling a more streamlined and faster access to the most relevant batch-related information.
- Paper vs. electronic batch records:
- Focus on FDA requirements
- Distinguishing mandatory data
- Defining a complete e-data set
- Expediting EBR integration & validation
Alex Smith, Director of Regulatory Sciences, HOGAN LOVELLS
10:30 Coffee & Networking Break
11:00 GROUP DISCUSSION: ACHIEVING REVIEW BY EXCEPTION THROUGH MANUFACTURING EXECUTION SYSTEMS
Implementation of a MES allows manufacturers to monitor key processes throughout production, ensuring each batch is produced within a controlled space. The ability to monitor in particular the weight, temperature and overall product quality allows batch record review to focus only on an exception to the manufacturing process, as it happens in real-time rather than after occurrence. By initiating the review at the first sign of exception, manufacturers can identify process errors and potentially save batches with immediate action.
- Effective implementation of review by exception:
- Enabling real-time review
- Ensuring review expedition
- Methodology development
- Overall positive impact on manufacturing
- Addressing the lack of implementation standards
Matt Gresh, MES Base Business Lead, JANSSEN
11:45 ANALYZING & FORECASTING DISRUPTIONS TO THE MES WORLD
As with all business solutions in the current market, certain disruptors cause a sudden change to operations in the life science industry, which can radically change demand from the consumer. Through thorough analysis of practical examples demonstrating the impact and outcomes of disruption on business solutions, such as disc compression software or dial-up internet providers, clarity will be provided on potential disruptors to the MES industry. With a deep focus on evolving technologies, trends, and customer needs, and the potential impact of all three factors on MES business solutions, participants will take away tools and insights to understand the various causes of upcoming disruptions to what the MES of the future resembles.
Joel Nichols, Head of Automation & Software, MILLIPORE SIGMA
Savvy Katham, Director of Program Portfolio, MILLIPORE SIGMA
12:30 Luncheon for all Participants
1:30 PERSONALIZED MEDICINE ADVANCEMENT & IMPACT ON MES
The pharmaceutical industry is progressively undergoing a shift towards personalized medicine, following the increase in providing patients with tailored treatments enabling a high rate of successful outcomes. The impact on MES is critical, as personalized medicine entails swiftly producing patient-specific drugs in small-scale batches, contrary to common manufacturing processes focused on standardization and minimizing the overall number of recipes for production. The current and ongoing healthcare focus on precision medicine promises to continue to raise challenges in Manufacturing Execution System architecture and the rapidly growing interest in implementing and achieving release by exception.
- Precision medicine specific manufacturing needs
- Release by exception implementation challenges
- Forecasting the increase in patient-specific production
Jordan Croteau, Senior Engineer, Execution Systems, BIOGEN
2:15 OPEN PROCESS AUTOMATION FORUM APPROACH FOR NEXT GENERATION CONTROL SYSTEM ARCHITECTURE
The Open Process Automation™ Forum is focused on developing a standards-based, open, secure, interoperable process control architecture. The forum is a consensus-based group of end users, system integrators, suppliers, academia, and standards organizations focused on addressing both technical and business issues for process automation. The Automation Forum addresses real challenges experienced by customer organizations across: Food and Beverage, Mining and Metals, Oil and Gas, Petrochemical, Pharmaceutical, Pulp and Paper, Utilities and Other industries. This presentation will cover the current direction of the next-generation process control framework design and implementation based on open architectural standards that seek to ensure new levels of cybersecurity, modularity, interoperability, extensibility, reuse, portability and scalability for future system designs.
Kirk Smith, Technology Working Group Co-Chair, OPEN PROCESS AUTOMATION FORUM
3:00 Closing Remarks & Conference Conclusion