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.

Speaker Board

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.

◆  Overview of the lifecycle of visual inspection systems in parenterals.

◆  Design, validation and monitoring stages for consistent inspection performance.

◆  Importance of ongoing maintenance and periodic requalification.

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

◆  Case studies highlighting the application of risk assessments in parenteral
inspections.

◆  How risk-based validation shapes equipment selection and inspection protocols.

◆  Comparing manual, semi-automated and automated inspection systems.

◆  Advantages and challenges of each approach for parenteral products.

◆  Criteria for selecting the best inspection approach for specific product lines.

◆  Essential skills required for inspectors handling parenteral products.

◆  Training programs and qualification processes for visual inspectors.

◆  The role of consistent inspector education in minimizing errors and improving
accuracy.

◆  Overview of two-stage inspection in the context of parenteral product quality
assurance.

◆  How two-stage systems improve defect detection and reduce the risk of overlooked
defects.

◆  Case studies demonstrating the efficacy of two-stage inspection approaches.

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

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

◆  Challenges and future trends in AI integration for parenteral product inspection.

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

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

◆  Standardization of defect classifications to maintain consistency.

◆  Types of particulate matter in parenterals (visible, sub-visible).

◆  Risks of particulate contamination in parenteral products.

◆  Detection methods and critical limits for particulate matter.

◆  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.

◆  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.

◆  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.

◆  Introduction to the Knapp test and its relevance to visual inspection of parenterals.

◆  Applications of the Knapp test for sensitivity testing in parenteral products.

◆  Limitations of the Knapp test and potential impact on defect detection accuracy.

Event Details