PDA EU00009 An Introduction to Visual Inspection: A hands-on course
Registration Options
Individual Registration
Group Registration
Program Highlights
The training course covers the fundamentals of visual inspection methods and their application to injectable products.
This training course covers the fundamentals of visual inspection methods and their application to injectable products. The detection and identification of visible particles is a key part of the course content, though container and closure defects are discussed as well. Students combine classroom review of current regulatory requirements and inspection methods with hands-on laboratory exercises to develop and practice practical inspection skills. The skills developed through this combination of classroom and laboratory exercises may be applied to manual human inspection, semi-automated and automated machine inspection methods. This is also an excellent opportunity to discuss your specific inspection questions and; challenges with expert instructors.
Who Should Attend
This course is designed specifically for:
- Injectable Drug Product Manufacturing Professionals and Management
- Quality Professionals and Management
- Validation and Manufacturing Engineers
- Technical Support Staff
- Product Development Scientists
- Inspection Equipment Manufacturers
Learning Objectives
Upon completion of this course, attendees will be able to:
- Understand current global regulatory and compendial requirements for visual inspection
- Understand patient risk associated with visible particles in injections
- Implement a technically sound and compliant inspection process
- Assess inspection performance
Contact
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Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Thursday, 11 April 2024
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 Training Course Day 1
Day 2
Friday, 12 April 2024
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
- ANSI/ASQ Z1.4
- ISO 2859
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
- Knapp Method
- 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 Training Course
Featured Trainers
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Markus Lankers, PhD
MIBIC GmbH & Co KG
Read BioMarkus Lankers, PhD
MIBIC GmbH & Co KG
Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.
Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.
He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the U.S.
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John G Shabushnig, PhD
Principal Consultant, Insight Pharma Consulting, LLC
Read BioJohn G Shabushnig, PhD
Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.
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PDA Europe has reserved a limited number of rooms by 12 February 2024.
Please be aware that those rooms are limited to that rate due to a city fair.
Book your room at the PDA Group Rate via the above-mentioned reservation button.