Post-Validation Training

Post-Validation Training

Strengthening Process Control, Compliance, and Audit Readiness Sterilization validation does not end with cycle approval. As regulatory expectations continue to evolve, maintaining validated conditions, controlling changes, and ensuring consistent routine release require structured expertise within internal teams.

To support this need, Medistri has developed a Post-Sterilization Validation Training program designed for medical device manufacturers seeking to reinforce in-house capabilities across validation, routine control, and regulatory compliance.

Delivered directly by sterilization specialists operating within an industrial contract sterilization environment, this training connects regulatory frameworks with real-world practices.

Following initial validation, sterilization processes enter a controlled operational phase where consistency, traceability, and compliance must be continuously demonstrated. This includes: From Validation to Routine Control

• Maintaining validated parameters within defined limits
• Managing changes, deviations, and impact assessments
• Ensuring alignment between process performance and regulatory expectations
• Preparing for audits through structured documentation and technical understanding

The training addresses these aspects through a combination of technical review, operational context, and applied examples.

Training Scope The program provides a structured approach to post-validation activities, covering both EO and steam sterilization processes. Key topics include:

Validation & Re-validation A step-by-step review of process qualification, including lifecycle considerations and requirements for maintaining validated states over time.

Routine Release Understanding parametric and microbiological release approaches, with focus on acceptance criteria, process monitoring, and documentation.

Regulatory Standards Application of key frameworks such as ISO 11135 (EtO sterilization) and ISO 17665 (Steam Sterilization), with emphasis on interpretation and implementation.

Real-World Application Case studies and troubleshooting scenarios reflecting operational challenges observed across industrial sterilization environments.

Process Integration Understanding how sterilization interacts with upstream and downstream activities, including packaging, logistics, and environmental considerations.

Training Formats and Delivery The training is designed to remain focused and practical, ensuring direct interaction with subject matter experts.

Duration: 6 hours (morning and afternoon, including lunch) Format: On-site (Medistri Switzerland or Hungary) or live virtual session Group Size: Maximum 5 participants Language: English

Certification: Issued upon completion On-site sessions include a process visit, allowing participants to observe sterilization processes and supporting infrastructure within an operational environment.

The program is intended for professionals involved in sterilization lifecycle management, including: Target Audience

• Quality Assurance and Regulatory Affairs teams
• Validation and Compliance Managers
• Internal sterilisation subject matter experts (SMEs)
• Production and Process Engineers

Operational Perspective In addition to regulatory alignment, the training integrates operational considerations observed across routine processing activities. For quality-focused teams, this includes:

• Improved audit readiness through deeper process understanding.
• Alignment on critical parameters, limits, and acceptance criteria
• Structured handling of change control and deviations post-validation
• Direct exposure to industrial sterilization processes

A Practical Approach to Training Unlike third-party training providers without direct sterilization operations, the Medistri program is developed and delivered within an active contract sterilization environment. This ensures that all content reflects current industrial practices, validated processes, and regulatory expectations observed across a broad customer base.

The training is open to both Medistri clients and non-clients, supporting access to applied knowledge without commercial bias.

Supporting the Sterilization Lifecycle Post-validation activities are critical to maintaining compliance and ensuring consistent product sterility. By strengthening internal expertise, organizations are better equipped to manage routine operations, respond to regulatory requirements, and maintain control over sterilisation processes across their lifecycle.

Medistri’s Post-Sterilization Validation Training is designed as a direct extension of this lifecycle approach, bridging validation, routine control, and operational execution.

Learn more about Medistri’s Post-Sterilization Validation Training, please contact your Customer Success Specialist or contact our team at development@medistri.com .

• The Medistri Team

Medistri

Medistri is Europe’s leading independent contract sterilization company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide.

We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech.

Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialization.

Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical back-end processes.

Our synchronized departments work together to provide a complete stack of services:

• Contract Sterilization & Validation Services
• Contract Laboratory Services
• Contract Manufacturing Services
• Logistics Services
• Consulting Services

We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.

Medistri Solutions for Products in Go-to-Market Phase

In the go-to-market phase, precision and speed are critical to demonstrate regulatory readiness, secure market access, and launch with confidence.

Medistri acts as your trusted, fully integrated infrastructure partner, providing a comprehensive suite of in-house Solutions tailored to support validation, submission, and commercial readiness.

Our solutions include packaging validation, shelf-life studies, cleaning & reprocessing validation, sterilization validation, custom cycle development, laboratory method validation, support-to-submission services, post-validation training, EO-free supply chain validation, CE Mark pathway consulting, and MDR transition consulting.

By managing the entire validation and compliance process under one roof in our Swiss facility, Medistri eliminates multi-vendor complexity, accelerates regulatory timelines, ensures consistent data quality and traceability, and allows your team to focus on strategic market entry and commercial execution.

Enabling a smooth, compliant transition from development to successful product launch.