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.
Upon completion of this course you will be able to:
- Understand current global regulatory and compendial requirements for visual inspection
- Understand patient risk associated with visible particles in injections
- Implement and technically sound and compliant inspection process
- Assess inspection performance
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, the attendee will be familiar with:
- 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
Instructors
John G. Shabushnig, PhD Principal Consultant, Insight Pharma Consulting, LLC
John Shabushnig is the founder of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience starting as a Research Scientist at The Upjohn Company and most recently as a member of Pfizer's Global Quality Operations, where he was responsible for providing microbiology and aseptic manufacturing technical support. 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 (PDA), having served on the Board of Directors (2003-2011) and as Chair (2008-2009) and is the founder and leader of the Visual Inspection Interest Group. He serves on the United States Pharmacopeia (USP) Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products.
Markus Lankers, Consultant
Markus Lankers is one of the co-founders of rap.ID Particle Systems GmbH, a company that develops, manufactures and sells rapid particle identification systems. Within rap.ID Markus is responsible for
research and development of specific characterization method of particulate analysis and manages two
dedicated particle characterization service labs in Germany and the US. Prior to this position, he worked
as scientist in different development departments with Schering AG, Berlin, Germany. He publishes
and presents work in the field of particle characterization and spectroscopic analysis. As an active member of the PDA, he has helped establish the PDA Visual Inspection Interest Group in Europe and set up the first company-independent Visual Inspection Trainings Course. He has served as program co-chair for the PDA Visual Inspection Forum in Europe and the USA.