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.