Visual Inspection mastery is fundamental in parenteral manufacturing in order to guarantee both patient safety and cost effective supply. The capability of Automated Visual Inspection (AVI) has progressed extensively over the years to the point where, when applied appropriately, it can offer significant advantages over manual and semi-automated inspection processes. This has been made possible thanks to major innovations and technology breakthroughs. In line with these technological advances, the regulatory requirements for this challenging process have been reinforced. As a consequence, AVI machines today are complex and require multidisciplinary project teams for successful implementation.
Who Should Attend
This course is designed specifically for those who are involved or interested in moving from manual to automated inspection like
- Managers, Supervisors and all Decision makers in the visual inspection area
- Quality personnel
- Prerequisites: Basic understanding and practical experience of manual inspection (as conveyed in the PDA course ‘Introduction to Visual Inspection’)
Learning Objectives
Upon completion of this course, you will be able to:
- Acquire basics about Regulatory landscape for AVI
- Be ready to design your URS
- Understand Key function of AVI equipment
- Define your defect kits and validation strategy
- Develop your own control strategy around AVI
- Test normallity at a glance, interpret, and communicate the results.
- Have basic knowledge about computer vision
Instructors
Romain Veillon, Senior Manager Visual Inspection & Leak testing, Global MSAT, GSK Vaccines
Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. Currently Romain focuses on Visual Inspection in a global function to support and advise GSK sites in the fields of Quality Integration Lead, Technology Development, Validation Strategy, Capability, Asset Management, Performance Improvement, and Develop Equipment strategy. Furthermore, he is managing a network of vision experts to develop visual Inspection expertise within GSK Vaccines. During the last 18 years he has worked in the area of parenteral manufacturing and has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines in different functions. Romain has developed innovative vision systems with some academic collaboration and is a frequent speaker at PDA conferences.
Fernand Koert, Consultant, Vision Technology, Dresden GlaxoSmithKline Vaccines
Fernand was born in the Hague, Netherlands and started his academic career at the Technical University of Delft to study Electronics. Working in that field, he completed career stages from shift leader to assistant plant manager. After gaining extensive practical experience, he started studying Process Technology at the Maritime Faculty in Amsterdam, graduating Cum Laude and working as a process engineer there after. In 2000, Fernand became a freelancer helping companies to set up practical training programs for operators. At Teva Pharmaceuticals, he did the same and became head of the packaging department in 2003. In 2005, he returned to technical engineering by assuming responsibility for reshaping and automation of packaging lines. Since 2011, Fernand has been specializing in vision technology, improving and sampling for test kits and validation. In 2014, he started with GSK, developing recipes for Seidenader AVI, first in Belgium, and currently for GSK in Dresden, Germany.
Sébastien Koch, Visual Inspection Project and Validation Engineer, Merck Switzerland
Sébastien has over 18 years field experience in visual Inspection. In 2000 he began his career for Eli Lilly as specialist in Vision technology to carry out Automated Visual Inspection Machines (AVIM) qualification, maintenance and continuous improvement. In 2010, as Green Belt Six Sigma Sébastien became lean manufacturing engineer to drive operational excellence. In 2012, he took over the lead as Responsible Engineer. In 2016, Sébastien joined Merck in Switzerland to support the Aubonne site development as a driver of change and progress. Responsible of the visual Inspection equipment, he leads the strategic roadmap for long term perspectives, the validation strategy and the permanent competitiveness improvements of the manufacturing processes for quality and cost efficiency.