Visual Inspection in Parenterals Summit 2025 - uventia

Visual Inspection in Parenterals Summit 2025

Visual-Inspection
Event Details

Conference Overview

The Visual Inspection in Parenterals summit is a premier event that brings together experts from the pharmaceutical and biotechnology sectors to explore best practices, technologies and advancements in the visual inspection of parenteral products.

Parenterals, which include injectable drugs and biologics, require stringent quality control measures to ensure their safety and efficacy. This conference will cover a wide range of topics such as the latest innovations in automated and manual visual inspection techniques, detection of particulate matter, container-closure integrity and regulatory requirements. Attendees will gain insights into cutting-edge technologies, industry standards and case studies aimed at enhancing the accuracy and reliability of visual inspections. The event will also provide valuable networking opportunities for professionals to collaborate and share expertise, fostering improvements in product quality and patient safety.

This conference is essential for anyone involved in the manufacturing, testing and regulation of parenteral products.

WE WILL TALK ABOUT

  • Regulatory and compendial requirements for visual inspection.
  • Comparing manual, semi-automated and automated inspection systems.
  • Training programs and qualification processes for visual inspectors.
  • Case studies demonstrating the efficacy of two-stage inspection approaches.
  • Detection methods and critical limits for particulate matter.
  • Considerations for setting acceptable limits and reducing risks.
  • Techniques for visual inspection of container integrity in parenterals.
  • Challenges of visual inspection for suspensions, emulsions and BFS parenterals.

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:

● Quality Control (QC)
● Quality Assurance (QA)
● Regulatory Affairs
● Manufacturing/Production
● Research and Development (R&D)
● Engineering and Validation
● Packaging
● Supply Chain
● Product Development
● Microbiology
● Clinical Affairs
● Technical Operations

Agenda Visual Inspection in Parenterals 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

Speaker Board
Jun Ordonez
Sr. Manager – Technical Services
Pfizer Inc.
Christoph Wey
QA Manager
Material Analytischer Service (M.A.S.)
Principal Consultant
Lachman Consultants
William Waterstreet
Principal Validation Engineer
Performance Validation
Elisabeth Wagner
Senior Lead Visual Inspection
CSL Behring
Bram Keymolen
Co-Founder | Compliance Director
eyetec
Felix Nikels
Senior Principal Scientist (DL)
Boehringer Ingelheim
Chiara Sinito
Head of AVI
WILCO AG
Andrea Sardella
Customer Success Manager
Brevetti CEA s.p.a
Massimo Frasson
CEO & General Manager
Brevetti CEA s.p.a
Antonio Burazer
Global Head Visual Inspection
Takeda

Summit Agenda

◆  Review of global regulations (FDA, EMA, ICH, GMP Annex 1) regarding visual inspection.

◆  Key compendial standards (USP , USP , Ph. Eur., JP).

◆  Responsibilities of manufacturers for compliance with visual inspection guidelines.

Takeda, AT

◆  Overview of the lifecycle of visual inspection systems in parenteral drug products.

◆  Lifecycle management of visible particulate matter: industry best practices.

◆  100% Inspection vs. 100% Detection.

Takeda, AT

◆  Introduction to the use of deep learning and AI in automating visual inspection.

◆  Benefits of AI for improving defect detection, classification and throughput.

◆  Unlocking Data for Smarter Production.

◆  Overview of Two-Stage Inspection Utilizing AVI Recirculation Function.

◆  Qualification.

◆  Reducing False Rejection.

◆  Risk Assessment..

◆  Evaluation of Historical Data / Trending.

◆  Defect Catalog, Library.

◆  Container Challenge Sets.

◆  Probability of Detection and Interpretation of Results.

◆  Training programs and qualification processes for visual inspectors.

◆  Test sets requirements.

◆  The role of consistent inspector education.

◆  Importance of a risk-based approach in the validation of visual inspection systems.

◆  Risk-based validation considerations for equipment selection and inspection protocols.

◆  How process controls and data integrity shapes risk-based validation of equipment.

◆  Classification of defects (cosmetic, functional, critical).

◆  Categorization schemes used in visual inspection (minor, major, critical).

◆  Standardization of defect classifications to maintain consistency.

◆  Particle Source Risk Assessment as the first step toward USP1790 and Annex 1 compliance.

◆  Types of particulate matter in parenterals.

◆  Risks of particulate contamination in parenteral products.

◆  Detection and characterization methods, critical limits and specifications for particulate matter.

◆  Techniques for visual and instrumental inspection of container integrity in parenterals.

◆  Leak detection technologies for syringes, vials and ampoules.

◆  Regulatory standards for container integrity and the impact of leaks on product safety.

◆  Standard reference test kit introduction.

◆  Creation of test kits for lyophilised products.

◆  Difficulties in the preparation of BFS standards.

◆  Infusion Bag test kits preparation.

◆  Challenges of visual inspection for suspensions, emulsions and BFS parenterals.

◆  Factors such as viscosity, opacity and particle size that complicate inspections.

◆  Best practices and solutions for inspecting these difficult-to-inspect products.

◆  Challenges of visual inspection for difficult to inspect parenterals (DIP).

◆  Automated visual inspection (AVI) of a fully assembled autoinjector.

◆  A Novel Approach for CCIT and AVI of Fusion-Sealed Pre-Filled Syringes (PFS) with opaque suspensions.

◆  Overview of acceptance sampling plans (AQL, zero defects).

◆  Statistical tools and methodologies for sampling in visual inspection.

◆  Considerations for setting acceptable limits and reducing risks.

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.

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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.

20% discount for 1 person registered, 25% discount per person if 2-3 bookings, and 30% discount per person if 4+

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

The discount is valid until 4th  of April 2025

Event Details