Wednesday, 22 May 2019
9:00
Welcome and Introduction
- Why We Inspect
- Patient Safety
- Regulatory Requirements
- Compendial Requirements
10:30
Coffee Break
11:00
Inspection Methods and Technologies
- Critical Parameters (lighting, time, contrast and motion)
- Manual Visual Inspection (MVI)
- Semi-Automated Visual Inspection (SAVI)
- Automated Visual Inspection (AVI)
12:30
Lunch Break
13:30
Particle Identification
14:30
Laboratory Exercise: Manual Visual Inspection
- Light Measurement
- Assessment effect of changing critical Variables
- Time (10 sec vs. 20 sec)
- Lighting (2,500 lux vs. 1,250 lux)
- Motion/Agitation (with vs. without)
15:30
Coffee Break
16:00
Continue Laboratory Exercise
17:30
Wrap-up Discussion / Q&A
18:00
End of Day 1
Thursday, 23 May 2019
9:00
Inspection Data Review
- From previous day’s laboratory exercise
10:00
Defect Classification Strategies
- Risk classification definitions
- Critical, Major and Minor defects
10:30
Coffee Break
11:00
Acceptance Sampling
- Sampling Plan Variables
- Sample SizeTime
- AQL and UQL
- Common Standards
12:00
Inspector Selection and Qualification
- Vision Screening
- Initial Training
- Initial Qualification
- Requalification
12:30
Lunch Break
13:30
Inspection Strategies
- Reinspection
- 2-Stage Inspection
- Focused inspection
- Empty Vial Inspection
14:00
Inspection Validation
- Inspection performance Assessment
- Acceptance Criteria
14:30
Coffee Break
15:00
Mythbusting
- Common misperceptions in visual inspection
15:30
Wrap-up Discussion / Q&A
16:30
End of Course