Welcome to day two of ValConnect 2022! We’re halfway through the conference, but there’s still much to share, and the momentum keeps building. Let’s dive right into a recap of day two.
Keynote: Building a Patient-Focused Proactive Learning System
The day started with an excellent keynote from FDA Case for Quality (CfQ) Program Manager Francisco (Cisco) Vicenty. He talked about how the FDA collaborates with industry to enable a highly connected device ecosystem to strengthen product quality, innovation, and safety. The desired future state is to move beyond compliance to a proactive learning system focused on patient quality outcomes. But there are barriers, many of which can be tied to the limited adoption of advanced technology and digital tools. Cisco spoke in detail about the CfQ initiatives designed to overcome these barriers, such as the CfQ Voluntary Improvement Program (VIP), CfQ Collaborative Community, Medical Device Information & Analysis Sharing (MDIAS) Platform & Partnership, and advanced manufacturing technology efforts.
Midway through the presentation, Cisco discussed the newly released computer software assurance (CSA) draft guidance, which he said is “intended to facilitate the adoption of automation and emerging digital technologies.” He noted that the benefit of technology in improving quality and safety for patients far exceeds the risks of the technology and the perceived value provided by the documentation/time burden of current expectations, then walked attendees through the new CSA approach.
In his closing remarks, Cisco noted that moving to this future state would require collaboration between the agency and industry, with patients and patient outcomes being the number one priority. Keep an eye on our blog for a deep dive into Cisco’s keynote and a link to the recording.
Tuesday’s Session Highlights
Here are some high-level takeaways from today’s 45-minute sessions. We plan to feature many of these sessions and links to their recordings in upcoming blog posts.
Session: Digital Transformation in Qualification & Validation
In our first Industry Insight session of the day, Head of Quality for Digital Transformation & Compliance Rajesh Thempadiyill walked us through Dr. Reddy’s Laboratories’ implementation of E-Val (ValGenesis) and his experience using the platform to validate its SAP S4/HANA Cloud ERP system. The pharma leader uses E-Val for computer system validation (CSV) and recently expanded its use to include equipment qualification (EQ). With this expansion came the challenge of establishing a strong training and support structure for its large user base, which the company overcame with the support of ValGenesis. Of particular interest to attendees were Rajesh’s tips for successful process mapping and simplification, as well as the efficiency gains he reported. Since implementing E-Val, the company has seen a 35-45% reduction in validation/qualification cycle time for CSV and a 25-30% reduction in validation/qualification cycle time for EQ.
Session: Using Templates for More Efficient Execution
When correctly designed, templates can save time, boost productivity, and guarantee consistency – but are you using them as effectively as you could be? In this enlightening Product Knowledge session, ValGenesis Project Manager Sandeep Lakshmanan showed attendees how to get more out of templates through header and body tags, table captions, and binding at proper levels. He also shared tips and best practices for using templates to enforce standardization and compliance.
Session: Introducing Next-Level Learning with ValGenesis University
ValGenesis VP of Learning Services Nancy Cattle delivered the first demo of the day for ValGenesis University, our new eLearning platform. ValGenesis University leverages the latest technology and creative instructional techniques to help users gain a solid understanding of our products, with the ultimate goal of improving your organization’s productivity and efficiency. Employees can learn at their own pace and repeat lessons if necessary. Managers can track employee learning. There are other benefits, too, such as increased user confidence, career advancement, and overall job satisfaction. For organizations, it’s an investment that can pay off in increased ROI and reduced employee turnover. The first rollout of courses will focus on the VLMS and e-Logbook products. Contact your ValGenesis account executive if you would like to learn more.
Session: Using Agile Methodology within ValGenesis
Why Agile in validation? According to Emmanuel Cansino, senior director of global industry solutions at ValGenesis, it is customer-centric, delivered quickly, allows teamwork and accountability, and provides flexibility in terms of changing requirements. ValGenesis technology mirrors the Agile software development process. In addition to a controlled framework, ValGenesis also enforces a disciplined, compliance-driven software design and development process and a change management framework to accommodate future system development iterations. Emmanuel demonstrated how scope changes precipitated by user story changes are easily addressed by the solution’s ability to dynamically maintain the requirements-to-test traceability matrix.
Session: Igniting Staff Engagement through Digital Transformation
Biotech startup Theragent is doing great things – and not just for clients and patients. The company is passionate about creating an outstanding digital-first work culture where employees feel valued and empowered. In our last Industry Insight session of the day, Quality Site Head Sang Yoon talked about Theragent’s commitment to values-based leadership and the Pharma 4.0 vision. He noted that providing a state-of-the-art facility and the most advanced digital tools is helping Theragent attract and retain top-tier talent. This presentation generated a fantastic Q&A session in which Sang was joined by Theragent’s Senior Validation Engineer Ana Martinez, who also serves as the ValGeneis sys admin. You can learn more about Theragent in this case study.
Session: Risk-Based Cleaning Validation Lifecycle: Live Product Tour
In our second demo of the day, Sunil Patel, ValGenesis’ director of product management, took us on a live tour of ValGenesis’ new cleaning validation solution while explaining the many benefits of a digitized and automated cleaning validation program. As Sunil demonstrated, the solution empowers users to automate worst-case product and worst-case equipment assessments, configure and automate MACO calculations, build critical cleaning matrices, create and execute cleaning validation documentation electronically, assess risk following ICH Q9 principles, and much more.
On tap for tomorrow: more great sessions, live demos, and a keynote address from Dr. Ajaz Hussain!
Join us for ValConnect 2023!
Next year’s conference will be a live event, so, in addition to fantastic keynotes and insightful product and industry sessions, they’ll be plenty of valuable networking opportunities, too. ValConnect 2023 will be held at the Hilton Clearwater Beach Resort & Spa in Clearwater, Florida, from Sept. 26-28.
Day two of ValConnect 2022 featured a live demo of ValGenesis University and a keynote from FDA's Cisco Vicenty. Read the recap!
Lisa Weeks, the marketing communications director at ValGenesis, writes extensively about technology, the life sciences and other regulated environments. Her work has appeared in many industry publications, including Life Science Leader, Quality Digest, Medical Product Manufacturing NEWS (MPMN), MedTech Pulse, Risk Insights, Medical Device and Diagnostic Industry (MD+DI), Medical Product Outsourcing (MPO), MedTech Intelligence, Pharmaceutical Processing, Pharma Manufacturing, Genetic Engineering & Biotechnology News (GEN) and Pharmaceutical Technology (PharmTech).