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PDA 593.1 Fundamentals of Automated Visual Inspection

Jun 09 - Jun 10, 2022
11:30 AM
-
2:30 PM
| Singapore Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This live eLearning training course will provide a basic understanding of the automated visual inspection (AVI) process and technology. Participants will learn how the capability of AVI process is dependent on the equipment, development and validation processes, as well as discuss the advantages and disadvantages of AVI technology. During this training course, participants will evaluate validation strategies to determine which approach to use under given circumstances. A case study will also be discussed.

This training course is an excellent opportunity to discuss questions that you have and to interact with others who are facing and overcoming the same inspection issues.

For more options and/or related training courses, please visit the page(s) below.

PDA Visual Inspection Training Courses

Agenda

  • Day 1
  • Day 2
  • Welcome and Introductions (10 min)


    Theory 1: Introduction into Regulatory Requirements (40 min)

    • USP 1, USP 788 and 1788, USP 790 and 1790, PhEur e.g. 2.9.20, JP e.g. 6.06, Annex 1 and Chinese Ph.
    • Similarities and differences in compendial methods
    • 100% inspection and AQL testing
    • Definitions and practical examples of inherent, intrinsic and extrinsic particles

    Theory 2: Technical Principles of Automated Inspection Machines Part I (60 min)

    • Functionality of automated inspection machines
    • Camera systems/light/motion
    • Image processing and database system

    Break (10 min)


    Theory 2: Technical Principles of Automated Inspection Machines Part II (60 min)

    • Interlinkage of parameters: speed, rotation speed, inspection parameters, detection probability, false reject rate
    • Properties, capabilities, and limitations of automated inspection systems
    • Scope of Automated Visual Inspection
  • Theory 3: Considerations on Primary Containers and Product Properties (60 min)

    • Vials, ampoules, syringes, blow-fill-seal
    • Viscous liquids, air bubbles/scratches
    • Refrigerated product containers

    Theory 4: Transition from Manual to Automated Inspection (50 min)

    • Manual inspection as a prerequisite for transition to automated inspection
    • Interpretation of inspection results and validation of data
    • Considerations on validation program for automated inspection
    • Performance measurement
    • Maintaining the manual inspection

    Break (10 min)


    Theory 5: Qualification Test Set and Routine Test Set (60 min)

    • Statistical considerations on number of objects containing defects
    • Particle selection, particle size and size uniformity
    • Test sets
    • Rejects and defects
    • Quality requirements

Trainers

Andrea Sardella
Andrea Sardella
Stevanato Group

Learning Objectives

  1. Apply the regulatory requirements for visual inspection to the automated environment
  2. Apply the knowledge of limitations of AVI inspection
  3. Evaluate validation strategies and be able to identify the most appropriate approach for defined circumstances
  4. Apply the knowledge of the functioning of AVI equipment to assess capability of performance
  5. Evaluate data from inspection program to identify potential program improvements and create solutions

Who Should Attend

This training course is intended for professionals who are involved in the development, validation and implementation of automated visual inspection systems for sterile drug manufacturing.

Departments
  • Quality Systems
  • Quality Compliance
  • Manufacturing
  • Quality Assurance Operations
  • Technical Operations
  • Validation

Roles
  • Analyst
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer

Registration Fees

Register Now
Registration Type Price
All Participants $599

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