Webinar - Turnkey Validation in PAS-X: Best Practices for Lean and Efficient Validation
In this session, we’ll explore how organizations can streamline their PAS-X validation approach, reduce complexity, and accelerate time-to-value. We’ll share best practices, highlight common pitfalls to avoid, and show how a turnkey strategy can deliver both compliance and efficiency.
Whether you’re new to PAS-X or looking to optimize your existing processes, this webinar will give you practical insights to make validation leaner, faster, and more effective.
Webinar Agenda:
1. Why Validation Matters
- Regulatory and authority obligations (FDA, EMA, GAMP 5)
- Business value beyond compliance: efficiency, quality, audit readiness
2. Evolution of Validation Approaches
- Effort, pitfalls, and benefits of each validation approach
- Industry shift toward lean, compliant strategies
3. Defining the Validation Scope
- Importance of structured risk assessment
- Leveraging vendor-provided documentation to optimize effort
- Balancing compliance, efficiency, and resource allocation
4. Core / Template Validation Approach
- Achieving efficiency in multi-site rollouts
- Harmonization and standardization across global operations
- Sustaining the Core / Template model over time
5. Initial Validation vs. Upgrades Validation
- Structured methods for identifying deltas and assessing impact
- Managing frequent upgrades and their validation impact
- Challenges and best practices in regression testing
6. Q&A Session
Featured Speakers:
- Denis Bele, Managing Consultant - PAS|X Excellence
- Sime Ivkovic, Senior Consultant- PAS|X Excellence
🔗 Register now!
Only registrations with business e-mail addresses will be authorized.