Validation University is a 3-day conference and training program that provides attendees with the latest knowledge and best practices in validation for the life sciences industry. The conference covers a wide range of topics, including Process Validation, Cleaning Validation, Computer System Validation / Computer Software Assurance, Equipment/Facility Qualification, and critical GMP processes that impact validation. Speakers are industry experts who share their insights and experiences on how to implement effective programs and the conference offers networking opportunities and hands-on, interactive training sessions.
Personnel In The Following Environments Should Attend:
- Validation
- QA/QC
- Engineering
- C&Q
- Regulatory and Compliance
- Facility Management
- Manufacturing
- Laboratory
This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.
Topic 1: Validation for Digital Threads
Date and Time: 24th April 2024 at 10:00 – 11:30 AM PST
Description:
Part 1 – DI Maturity: What is it?
- Understand the critical elements of a data integrity program: assessing computerized systems, building procedural and technical controls, improving behaviors
- Understand why building a data integrity maturity model is critical to your organization
- Learn how to assess your organization’s data maturity
- Identify attributes to improving technical, procedural, and behavioral data integrity
- Learn what a data governance maturity model is and which model your organization should use
Part 2 – DI Maturity:The How
- Learn how to identify data vulnerabilities
- Understand the importance of interconnectivity and Pharma 4.0 in maturing data integrity in your organization
- Review a failed data integrity program case study: what went wrong?
- Review a successful data integrity program case study: what caused its success?
- Identify real technical solutions to computerized systems that will enhance data integrity maturity
Knowledge Exchange:
- Attendees take part in a round-the-room conversation comparing real life DI challenges in today’s industryTakeaway Tools
- Examples of real-life DI challenges in programs and what we can do to improve
Speakers:
🎤 Francisco Vicenty: Case for Quality Program Manager, U.S. FDA (Invited)
🎤 Daniel Walter: Policy Analyst, CDRH, U.S. FDA (Invited)
🎤 Jason Spiegler: SVP Strategy & Customer Experience, Compliance Group (Invited)
Topic 2: Integrated Compliance – Synergy between GxP and Other Regulatory Requirements
Date and Time: 24th April 2024 at 3:00 – 3:40 PM PST
Description:
Understanding Integrated Compliance: An Overview
- Exploring the Essence of Integrated Compliance
- Recognizing Pain Points and Unveiling Benefits
Roadmap to Success
- Essential Factors for Achieving Integrated Compliance Excellence
Navigating the Landscape: Key Functions of Integrated Compliance
- Compliance Management: Streamlining Regulatory Adherence
- Process Management: Enhancing Operational Efficiency
- Policy and Documentation Management: Ensuring Governance and Traceability
Speakers:
Speakers:
🎤 Mark Lawson: Executive Director of Quality and Compliance Group
🎤 Lakshmi Chitrapu: Manager, Quality and Compliance, Compliance Group