Particle Identification in Parenterals - Training / Workshop von PDA Europe gGmbH

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.

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.

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