Particulate matter contamination has become the #1 reason for recalls of the US-FDA. This one day comprehensive training course taught by industry leading experts will offer strategies for the implementation of a cost effective control through mandatory compliant root-cause investigations.
The program will provide the foundational information needed to properly control, document and investigate foreign particulate matter in parenteral drugs. It will provide the perfect balance of hands-on laboratory and lecture training, equipping you with knowledge, tools and actual experience you can apply immediately on the job. Furthermore the course will provide insights and practical guidance for the quality teams to develop a cost–effective strategy for the critical routine root cause investigations to ensure compliance with current good practices.
With a strong emphasis on the hands-on part the participants will learn the theoretical background of useful microscopic and spectroscopic techniques. Pre-isolation: in-situ Microscopy (inverse microscope) and other means of video microscope to visualize and document the particulate matter without opening the container. Isolation: Tools and precautions to minimize cross contamination for the isolation of the micro particles. After isolation: Pro´s and Con´s of Polarized Light Microscopy and micro-spectroscopic techniques such as: Raman, Laser Induced Breakdown Spectroscopy, LIBS and IR with ATR extension and SEM EDS will be critically discussed.
rap.ID Particle Systems GmbH
Köpenicker Strasse 325, House 11/12
12555 Berlin (Germany)
Who Should Attend
This course is designed specifically for those involved or interested in the manufacture and control and CMC regulatory issues of biopharmaceuticals, including Senior Management, Directors and Managers / Supervisors, QA/QC, Regulatory Affairs, Manufacturing and Process Development Personnel
Upon completion of this course, the attendee will be familiar with:
- Understand the principles of particulate matter characterization in the closed container by means of micro imaging photo documentation as well as visual observations.
- Explain the strategy of compliant particle root-cause investigations including reference material library building.
- Understand and gauge the results of particulate material identification from micro spectroscopic methods such as: Raman, IR with ATR, EDS and LIBS.
Oliver K. Valet, PhD Managing Director, rap.ID Particle Systems GmbH
Oliver K. Valet is one of the co-founders of rap.ID Particle Systems GmbH, a company that develops, manufactures and sells rapid particle identification systems. Within the last 15 years, their patented technology fuses particle isolation, imaging analysis and spectroscopic technology together to powerful investigation tools. Streamlining particle contamination identification and particle characterization. Within rap.ID, Oliver is responsible for the product development and their worldwide marketing and sales. From the contract testing work performed at both rap.ID sites in Berlin and Princeton, New Jersey, Oliver has more than a decade of experience in the field of industrial and environmental chemical analysis on particles. As an active member of the Respiratory Drug Delivery (RDD), the Royal Chemical Society, the Parenteral Drug Association (PDA), the American Association of Pharmaceutical Science (AAPS) and the Apothekerverband (APV), he has published his work continuously and presented on various conferences.
Markus Lankers, PhD Managing Director, rap.ID Particle Systems GmbH
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.