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Parenteral Drug Association Connecting People, Science and Regulation ®

Particle Identification in Parenterals

Sep 25 - Sep 25, 2017 |
Sep 25, 2017 |
rap.ID Particle Systems GmbH | Berlin, Germany
  • Education
  • Europe
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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.

Training Location

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

Learning Objectives

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.

Instructors

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.

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.


Monday, 25 September 2017

9:00
Welcome & Introduction

09:30
Strategies for Particle Classification, Characterization, Particle Isolation

11:00
Coffee Break

11:30
Hands-on: Particle Detection, In-situ Microscopic Characterization

12:30
Lunch Break

13:30
Hands-on: Isolation of Particles

14:30
Hands-on: Spectroscopic Identification of Particles
15:30
Coffee Break

16:00
Challenges in Particle Identification

17:00
Summary of the Course, Q&A

17:30
End of Training Course and Bus Transfer from rap.ID GmbH to Conference Hotel (optional - duration approximately 45 - 60 min.)

4 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

845 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0)30 43 655 08-10
Fax: +49 (0)30 43 655 08-66
Email

Training Location

rap.ID Particle Systems GmbH
Köpenicker Strasse 325, House 11/12
12555 Berlin
Germany

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://www.pda.org/docs/default-source/website-document-library/eu-conferences/2017/09_particles-in-injectables/registration-form.pdf

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