PDA 417.1 Introduction to Visual Inspection
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Registration Options
Individual Registration
Group Registration
This live eLearning training course covers the fundamentals of visual inspection and their application to injectable products. The skills developed through this training course may be applied to both manual human inspection and automated machine inspection.
During this training course, you will learn about patient risks associated with particles in injections; global compendial and regulatory requirements and expectations; inspection techniques for visible particles and container closure defects; critical quality parameters for manual, semi-automated and automated inspection methods; light measurement and control; key elements of a visual inspection program; and inspection lifecycle development.
- Identify applicable international regulatory and compendial requirements for visual inspection
- Apply the critical parameters which must be controlled for reproducible inspection results
- Use appropriate statistical tools to assess and compare inspection methods
- Develop consistent validation strategies for visual inspection processes and equipment
Agenda
Discover What's Happening Each Day
Why We Inspect (60 min)
- Why We Inspect
- Regulatory Requirements – FDA (Recalls/483’s; FD&C Act), EMA (Annex 1)
- Compendial Requirements (USP, EP, JP)
- Other Standards
Break (10 min)
Inspection Methods and Technologies (20 min)
- Manual Inspection
- Critical Parameters (Lighting, Duration/Speed, Contrast, Agitation)
- Semi-Automated Inspection
- Automated Inspection
Break (10 min)
Manual Inspection Exercise (50 min)
- Basic Inspection Method Instruction
- Light Measurement
- Effect of Critical Inspection Parameters on Particulate Inspection (Time, Lighting, Agitation)
- Inspection Process Data Review (typical class inspection data analysis)
Wrap-Up Discussion / Q&A (30 min)
Defect Classification Strategies (30 min)
- Defect Definitions (Critical, Major, Minor)
Inspector Selection and Qualification (30 min)
- Vision Screening (Acuity, Correction, Color Blindness)
- Initial Training
- Initial Qualification
- Periodic Requalification
Break (10 min)
Acceptance Sampling (50 min)
- Sampling Plan Variables (Operational Characteristic Curves, AQL’s and UQL’s, Sample Size)
- ANSI Z1.4
- Single and Double Sampling Plans
Inspection Strategies (30 min)
- Reinspection
- 2-Stage Inspection
- Focused Inspection
- Empty Vial Inspection
Myth Busting / Wrap-Up Discussion / Q&A (30 min)
Registration
Pricing Options
Standard Registration
Member Price
$699GovernmentMember Only
$699
Health AuthorityMember Only
$699
Early Career ProfessionalMember Only
$699
StudentMember Only
$699
AcademicMember Only
$699
Non-Member
$699
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
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Become a Sponsor
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Boost your brand and visibility by becoming an exhibitor at the PDA 417.1 Introduction to Visual Inspection! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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