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The training course covers the fundamentals of visual inspection methods and their application to injectable products. It will be a combination of lecture/discussion and hands-on laboratory exercises used to develop and practice practical inspection skills. The skills developed through this course may be applied to both manual human inspection and automated machine inspection.
Join instructors John Shabushnig and Markus Lankers for this extremely informative and popular course! This course has sold out early the past three times it has run. Register early before this course is sold out again!
Upon completion of this course you will be able to:
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
Who Should Attend
Pharmaceutical/Biopharmaceutical | Development | Engineering | Manufacturing |
Packaging | Process Development | Quality | Technical Services | Validation | Inspection
Equipment Suppliers | Applications Development | Machine Design | Purchasing
Faculty
John G. Shabushnig, PhD, Insight Pharma Consulting, former Pfizer, USA
Markus Lankers, PhD, rap.ID Particle Systems, Germany
Program:
Day 1
| 08:30 - 09:00 |
Registration
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| 09:00 - 10:30 |
Why We Inspect
Regulatory and Compendial Requirements
– USP, EP/BP, JP, WHO, FDA, Aseptic Guidance 483’s,
EMEA, Annex 1 |
| 10:30 - 11:00 |
Coffee Break |
| 11:00 - 12:30 |
What We Are Looking For
- Defect types
- Foreign material / particulates
- Container – Closures
How We Inspect
- Manual Inspection
- Critical parameters – Lighting – Duration –Agitation – (Magnification)
- Semi-automated Inspection
- Automated Inspection
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| 12:30 - 13:30 |
Lunch Break |
| 13:30 - 15:30 |
Laboratory: Manual Inspection Exercise
Basic inspection method instruction
Effect of critical inspection parameters on particulate inspection
Time (5 sec, 15 sec)
Lighting (2500 lux, 1250 lux)
Agitation (with and without) |
| 15:30 - 16:00 |
Coffee Break |
| 16:00 – 17:30 |
Effect of critical inspection parameters - Continued |
| 17:30 - 18:00 |
Wrap-up discussion / Q&A |
Day 2
| 09:00 - 10:30 |
Inspection Data Review (from previous day’s lab)
Defect Classification Strategies
– Critical /Major / Minor |
| 10:30 - 11:00 |
Coffee Break |
| 11:00 - 12:30 |
Acceptance Sampling
Sampling Plan Variables
– Operational Characteristic Curves –
AQL’s and UQL’s – Sample size – ANSI Z1.4
– Single and Double Sampling Plans
Inspection Strategies – Reinspection – 2-Stage
Inspection – Focused Inspection – Empty Vial Inspection |
| 12:30 - 13:30 |
Lunch Break |
| 13:30 - 14:30 |
Inspector Selection and Qualification
- Vision Screening
- – Acuity – Correction – Color Blindness
- Initial Training
- Initial Qualification
- Periodic Requalification
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| 14:30 - 15:00 |
Inspection Validation Methods
Comparing Inspection Methods
Acceptance Criteria |
| 15:00 - 15:30 |
Coffee Break |
| 15:30 – 16:30 |
Particle Identification |
| 16:30 - 17:00 |
Wrap-up discussion / Q&A |
Participation Fees:
Members: 6500 NIS
Non Members: 7500 NIS (This includes 1 year PDA membership).
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