Schedule
Session Topics
Two tracks over two days, including 16 sessions, dinners, networking, and social events. Customers join early, with a special social event the night before the conference and customer-exclusive pre-event sessions on Day One.
Agenda
COMING SOON
Attendees will hear from leading validation and quality professionals, as well as Kneat and industry experts to expand their understanding of the technologies and best practices to unlock data driven quality. We’re in the final steps of setting the agenda, check back soon for a full list of sessions!
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Tuesday
April 18
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Wednesday
April 19
8:30 am
Registration
Registration & Breakfast
Lobby
9:15 am
10:15 am
Break
Lobby10:30 am
11:15 am
12:00 pm
Lunch
The Brasserie Restaurant12:30 pm
Registration
General Conference Registration
Lobby1:15 pm
Keynote | The Power of AI in Life Sciences: Challenges and Opportunities
Artificial intelligence is probably the most disruptive technological development in human history, and it is ubiquitous; from the face recognition on your smartphone to advanced medical research, from payment fraud detection to industrial robots. In addition, other emerging technologies such as internet of things, blockchain, and virtual reality complement and interact with artificial intelligence to create even more immersive, complex, and disruptive products and services. But what is AI really, what is it not, and how can the life science industry benefit from the advantages whilst abiding by the requirements for quality control, traceability, and compliance?
Elin Hauge
AI Expert & Futurist
2:00 pm
Transition
Transition
2:05 pm
Session 1.2
How Fedegari Digitized Equipment Manufacturing Validation to Streamline Commissioning & Qualification
- The role of equipment manufacturers in C&Q lifecycle
- Partnering with No Deviation to implement Kneat Gx
- Applying KneatGx to Fedegari’s manufacturing lifecycle to support qualification
- Using data captured in Kneat to pursue faster time to market”
2:50 pm
Break
Lobby3:10 pm
Session 2.1
How Novartis is Enabling its Engineering Vision with Kneat
- Novartis’ digital vision
- Understanding challenges and identifying opportunities for digital validation
- Building a business case to implement digital validation
- Educating and gaining buy-in from executives
- Scaling digital validation to maximise benefits
Session 2.2
PANEL DISCUSSION: Digitization and Change Management
- How can validation leaders best manage change arising from ever-increasing use of digital technologies?
- How can digital validation help resolve the growing human resources challenges facing validation teams?
- What training do digital validation professionals need to keep up with change in the validation industry?
3:55 pm
Transition
4:00 pm
Session 3
How Gilead Sciences Ireland Migrated to Paperless Validation with Kneat
- How and why Gilead digitized all Validation activity in GSIUC
- Results and Lessons Learned of digitizing Validation at GSIUC
- How Gilead is using Kneat to implement CSA in line with FDA Draft Guidance/Updated GAMP 5 Guidance.
4:45 pm
5:00 pm
Happy Hour
5:45 pm
Bus to Offsite Dinner
Foyer6:00 pm
Offsite Event
10:15 pm
Return to Hotel
Foyer8:30 am
Breakfast
Continental Breakfast
Lobby9:00 am
Session 4
How AbbVie Achieves Data Driven Quality in Commissioning & Qualification
- Creating a sound analytical foundation through Data Integrity
- Using digital validation data to drive Good Engineering Practies
- Creating your own data driven C&Q process with best practice off-the-shelf content
9:45 am
Transition
9:50 am
10:35 am
Break
Lobby10:55 am
Session 6.1
Harmonizing Quality & Engineering at Amgen
- QRES process aligning business, quality and engineering goals
- How Amgen implemented Kneat to harmonize CQV across all stakeholders
- Key Kneat functionality enabling harmonization
Session 6.2
PANEL DISCUSSION: Kneat Services in Industry
- Enabling customers to maximize the value of KneatGX
- Ensuring quality services ensures higher compliance.
- Knowledge Sharing and Best Practices
11:40 am
Transition
11:45 am
Session 7.1
Digitizing Computer System Validation to Enable Efficient CSA
- How Kneat is transforming validation in Life Sciences
- Why Kneat is trusted by Life Sciences industry leaders
- Walkthrough of latest Kneat Gx release
12:30 pm
Lunch
The Brasserie Restaurant1:30 pm
Session 8
Workshop: Company Operations & Work Processes
In this interactive workshop, attendees will engage in facilitated discussions about their organization’s operations practices, work processes and methods.
2:15 pm
Session 9
PANEL: Creating a Business Case for Your Validation Software Project
- What do validation professionals need to know about their organization in order to create an effective business case?
- After a business case is developed and successful, what happens next?
- What are some of the key pitfalls and learnings from your experiences with business cases?
3:00 pm
Session 10
Shifting Focus From Documentation, to Data
- Understanding the roles of and differences between data and documentation
- Harmonizing validation work processes to enable data driven documentation
- Applying technology to leverage and manage the data
