2nd Annual Cleaning Validation Summit 2025 - uventia

2nd Annual Cleaning Validation Summit 2025

2nd Annual Cleaning Validation Summit 2025
Event Details

Conference Overview

Join us for the 2nd Cleaning Validation Summit, a premier two-day event dedicated to best practices, regulatory expectations and emerging trends in pharmaceutical cleaning validation. This summit will bring together industry experts, regulatory professionals and practitioners to discuss critical topics, from regulatory guidelines (FDA, EMA, PIC/S) to risk-based cleaning validation strategies.

Day 1 focuses on fundamentals, covering key topics such as cleaning process development, analytical methods, protocol documentation and visual inspection—a crucial aspect of contamination control.

Day 2 delves into advanced concepts, including lifecycle approaches, equipment cleanability, risk-based validation and troubleshooting common failures. Participants will also gain insights into automation, real-time monitoring and case studies from industry leaders.

Don’t miss this opportunity to expand your expertise, engage in discussions and stay ahead of regulatory expectations. Secure your spot today!

We Will Talk About

  • Regulatory Expectations & Guidelines.
  • Cleaning Process Development.
  • Cleaning Validation Protocol & Documentation.
  • Analytical Methods for Cleaning Validation.
  • Establishing Limits & Acceptance Criteria.
  • Visual Inspection in Cleaning Validation.
  • Cleaning Validation Lifecycle Approach.
  • Equipment Design & Cleanability Studies.
  • Risk-Based Approach in Cleaning Validation.
  • Cleaning Validation Failures & Troubleshooting.

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 2nd Annual Cleaning Validation Summit 2025

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
Cleaning Validation Summit
Expired
[•REC] - €375
October 1, 2024

Speaker Board
Joe Cagnassola
Sr Tech Transfer Leader
Fresenius Kabi, LLC
Sharif Uddin
Principal Engineer, Process Cleaning
Rockline Industries, Inc
Kenneth Pierce
Director of Product, Process & Cleaning Validation
ValGenesis Inc.
Andreas Schreiner
Validation Leader
Novartis
Richard Forsyth
Principal Consultant
Forsyth Pharmaceutical Consulting
Ram Kouda
Scientific Associate Director
Amgen
Brian Bosso
Technical Service Manager
STERIS Corporation
Mariann Neverovitch
Sr. Manager Logistics Operations
Bristol-Myers Squibb
Fred Ohsiek
Associate Director of Cleaning Validation
Eliquent Life Sciences
Thomas Altmann
Global Technical Consultant
Ecolab Deutschland GmbH

Summit Agenda

◆  What is Digitalised Cleaning Validation.

◆  What are Regulatory Expectations around Digitalisation.

◆  How does a Digitalised Programme solve for multiple issues in Cleaning Validation.

◆  Regulatory expectations.

◆  Laboratory bench scale studies / cleanability trials.

◆  Implementation on-site.

◆  Levels of cleaning and level of documentation.

The key to success in any cleaning program is having a cleaning protocol and report that captures the critical steps and provides audit ready documentation. Understanding the cleaning process/program helps the users write polished documentation that stands up to the scrutiny of auditors. This presentation will go step by step through the inception of the cleaning project through the completion of the report. Understanding the process flow will help expedite the Validation time and ensure compliance to internal and external requirements.
Learning Goals for this presentation include: • User Requirements • Pre-Requisites to get started writing • Understanding the Writing Process • Execution and Report Writing.

◆  Common analytical techniques (HPLC, TOC, UV-Vis).

◆  Sensitivity, specificity and validation of analytical methods.

◆  Recovery studies and swab sampling considerations microbiological testing.

◆  Basics of limit parameters.

◆  Limit calculations.

◆  Practical considerations in applying limits / acceptance criteria.

Forsyth Pharmaceutical Consulting, USA

◆  Regulatory expectations for visual inspection.

◆  Establishing visibility limits for residues.

◆  Case study: Challenges and best practices in visual inspection.

Forsyth Pharmaceutical Consulting, USA

◆  Regulatory requirements.

◆  Case Study.

◆  Learnings from Inspections.

◆  Real-time monitoring techniques.

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

◆  Bridging lab scale and full-scale testing.

◆  Components of Cleaning Life Cycle.

◆  Role of Hygienic Design in Cleaning Validation.

◆  Continuous Monitoring and Revalidation.

◆  Review of regulatory requirements and guidelines.

◆  Initial CV RA (validation risk/scope/footprint).

◆  Living CIP/COP/manual cleaning RA.

◆  Equipment grouping risk assessment.

◆  Ongoing monitoring program RA (frequency and type of sampling).

◆  Miscellaneous Ras.

Registration Tickets

25% discount for 1 person registered, 30% discount per person if 2-3 bookings, and 35% discount per person if 4+,. The discount is valid until 20th of June 2025

To receive a discount coupon, email us at info@uventia.com or submit a REQUEST BROCHURE.

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.

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.

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