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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.
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Apply the critical
parameters which must be controlled for reproducible
inspection results
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Use appropriate
statistical tools to assess and compare inspection
methods
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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
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08:30 - 09:00
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Registration
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09:00
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10:30
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Why We
Inspect
Regulatory and Compendial
Requirements
– USP, EP/BP, JP, WHO,
FDA, Aseptic Guidance 483’s,
EMEA,
Annex 1
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10:30
- 11:00
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Coffee Break
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11:00 - 12:30
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What We Are
Looking For
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Defect
types
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Foreign material /
particulates
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Container –
Closures
How We
Inspect
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Manual
Inspection
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Critical parameters
– Lighting –
Duration –Agitation
– (Magnification)
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Semi-automated Inspection
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Automated Inspection
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12:30 - 13:30
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Lunch Break
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13:30 - 15:30
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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)
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15:30 - 16:00
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Coffee Break
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16:00 –
17:30
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Effect of
critical inspection parameters - Continued
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17:30 - 18:00
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Wrap-up
discussion / Q&A
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Day 2
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09:00
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10:30
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Inspection Data
Review (from previous day’s lab)
Defect Classification Strategies
–
Critical /Major / Minor
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10:30
- 11:00
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Coffee Break
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11:00 - 12:30
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Acceptance
Sampling
Sampling Plan Variables
– Operational Characteristic Curves
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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
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12:30 - 13:30
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Lunch Break
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13:30 - 14:30
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Inspector
Selection and Qualification
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Vision
Screening
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– Acuity –
Correction – Color
Blindness
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Initial
Training
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Initial
Qualification
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Periodic Requalification
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14:30 - 15:00
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Inspection
Validation Methods
Comparing Inspection
Methods
Acceptance Criteria
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15:00 - 15:30
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Coffee Break
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15:30 –
16:30
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Particle
Identification
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16:30 - 17:00
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Wrap-up
discussion / Q&A
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Participation Fees:
Members: 6500 NIS
Non
Members: 7500 NIS (This includes 1
year PDA membership).
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