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.

Previous Events
Cleaning Validation Summit
Expired
[•REC] - €375
12:30 pm

Speaker Board
Mariann Neverovitch
Sr. Manager Logistics Operations
Bristol-Myers Squibb

Summit Agenda

◆  FDA & EMA guidance on cleaning validation.

◆  Understanding PIC/S Annex 15.

◆  Common regulatory findings and how to avoid them.

◆  Selection of cleaning agents and parameters.

◆  Risk-based approach in cleaning validation.

◆  Role of Quality by Design (QbD) in cleaning.

◆  Components of a cleaning validation protocol.

◆  Acceptance criteria for residues and contaminants.

◆  Documentation best practices.

◆  Calculation of Maximum Allowable Carryover (MAC).

◆  Health-based exposure limits (HBEL).

◆  Worst-case product and equipment selection.

◆  Regulatory expectations for visual inspection.

◆  Establishing visibility limits for residues.

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

◆  Cleaning validation vs. verification.

◆  Continuous monitoring strategies.

◆  Periodic review and revalidation.

◆  FMEA (Failure Mode and Effects Analysis) in cleaning.

◆  Risk ranking and risk control strategies.

◆  Case study: Risk assessment in multi-product facilities.

◆  Common failure modes and root causes.

◆  Investigations and corrective actions.

◆  Case study: Resolving cleaning validation failures.

◆  PAT (Process Analytical Technology) in cleaning validation.

◆  Real-time monitoring techniques.

◆  Digital solutions for cleaning validation compliance.

◆  Lessons learned from global audits and inspections.

◆  Industry trends and innovations in cleaning validation.

◆  Practical strategies for successful implementation.

Registration Tickets

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

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.

Event Details