3rd Annual Cleaning Validation Summit 2026

Cleaning Validation
Event Details

Conference Overview

From Fundamentals to Lifecycle Control in a High-Scrutiny Environment

Join us for the 3rd Annual Cleaning Validation Summit, a two-day virtual event dedicated to the latest regulatory
expectations, best practices and real-world challenges in pharmaceutical cleaning validation. Building on the success
of the 2025 edition, the 2026 summit reflects how the industry has evolved in response to increased regulatory scrutiny,
Annex 1 implementation, digital transformation and more complex product portfolios.

Day 1 reinforces core principles and regulatory alignment, incorporating inspection trends observed in 2025.

Day 2 focuses on advanced lifecycle management, risk-based decision-making, automation and complex case studies,
supporting sustainable, inspection-ready cleaning validation programs.

We Will Talk About

  • Regulatory Expectations & Inspection Trends.
  • Equipment Design & Cleanability Studies.
  • Cleaning Validation Protocols & Documentation: Inspection-Ready in 2026.
  • Analytical & Microbiological Methods for Cleaning Validation.
  • Cleaning Validation Lifecycle Approach.
  • Visual Inspection as a Contamination Control Tool.
  • Cleaning process development and cleaning agent selection.
  • Limit setting and visual clean – how does this fit together?
  • Risk-Based Cleaning Validation in Complex Facilities.
  • Cleaning Validation Failures & Troubleshooting.
  • Continuous Process Verification, Automation & Digitalisation.
  • Case Studies & Industry Best Practices.

Who Is It For?

The event covers key areas of product quality, regulatory compliance and manufacturing processes. The following departments would benefit from the insights shared at the conference:

● Cleaning Validation/ Containment)
● Bioprocessing/ Bioproduction
● Aseptic Processing
● Sterility Assurance
● Manufacturing Science & Technology
● Good Manufacturing Practice (GMP)
● Cleaning Products/ Detergents
● Risk Management
● Quality Assurance
● Quality Control
● Analytical Development
● Regulatory Affairs

Agenda 3rd Annual Cleaning Validation Summit 2026

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

Previous Events
2nd Annual Cleaning Validation Summit 2025
October 1, 2025
A premier two-day event dedicated to best practices, regulatory expectations and emerging trends in pharma cleaning validation. [Recording: 16 video sessions].
Expired
[•REC] - €345
Cleaning Validation Summit
October 1, 2024
Looking to build compliant cleaning validation program and ensure that your next product is not affected by contamination? [Recording: 14 video sessions].
Expired
[•REC] - €295

Speaker Board
Joe Cagnassola
Sr Tech Transfer Leader
Fresenius Kabi, LLC
Liz Dallison
Analytical Chemist
Pfizer (Retired)
Jenna Carlson
President & Quality Consultant
Mindful Quality
Brian Bosso
Technical Service Manager
STERIS
Thomas Altmann
Global Technical Consultant
Ecolab Deutschland GmbH

Summit Agenda

◆  Impact of equipment design on cleaning effectiveness.

◆  Cleanability challenges across dosage forms (OSD, liquids, biologics).

◆  Hygienic design considerations aligned with Annex 1.

◆  Case studies from challenging equipment and retrofits.

◆  Essential elements of modern cleaning validation protocols.

◆  Aligning acceptance criteria with toxicology and analytical capability.

◆  Documentation practices supporting data integrity and traceability.

◆  Common documentation gaps identified during inspections.

◆  Analytical techniques (HPLC, TOC, UV-Vis) and rapid methods.

◆  Validation of analytical methods.

◆  Recovery studies.

◆  Microbiological testing.

◆  Regulatory expectations for visual inspection programs.

◆  Establishing and justifying visibility limits.

◆  Integration with analytical results and CCPs.

◆  Case study: visual inspection failures and remediation.

◆  Regulatory expectations.

◆  Laboratory bench scale studies / cleanability trials.

◆  Implementation of cleaning process on-site.

◆  Levels of cleaning and level of documentation requiered.

◆  Limit calculation for cleaning validation (HBEL, fixed limits, TTC).

◆  Points to consider for limit setting.

◆  Visual clean - regulatory requirements.

◆  Determination of visual residues limit (VRL).

◆  Case study Paracetamol and visual clean.

◆  Applying FMEA and other risk assessment tools.

◆  Risk ranking, control strategies and justification.

◆  Managing shared equipment and multiproduct facilities.

◆  Case study: defending risk-based decisions during inspections.

◆  Common failure modes identified in 2025.

◆  Root cause investigations and CAPA strategies.

◆  Documentation, training and procedural gaps.

◆  Case study: remediation of a failed cleaning validation program.

◆  Real-time monitoring techniques.

◆  Analytical methods in PAT for in-line, on-line and at-line testing.

◆  Bridging lab scale and full-scale testing.

◆  Case Studies for PAT in Cleaning Validation.

◆  Lessons learned from global audits and inspections.

◆  Innovations in cleaning validation and monitoring.

◆  Recovery studies.

◆  Practical strategies for sustainable, inspection-ready programs.

Registration Tickets
most popular
2 Days Ticket + Recording
595

Full access to the 2 days online event.

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

1 Day Ticket + Recording
415

Full access to the 1 day online event.

Recording of 1 day event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

2 Days Recording
495

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

To register to the summit as a Delegate, complete the registration form. After submission, you will receive confirmation and invoice. Registration for the virtual event covers access to all online material in the Proceedings including keynotes, PDF presentations and papers, posters, and delegate list with contacts as well as video recordings of speakers' speeches.

If you need more information, please contact us at info@uventia.com

Event Details