Foreign Particulate Matter Control Stages Training Program

Foreign Particulate Matter Control
Stages Training Program
March 15th, 2016 - Monmouth Junction, NJ
The attention on foreign particulate contamination on parenteral drug products is strongly growing. Besides the
loss of product, the impact on reputation can generate immense losses.
This one-day comprehensive training program will be taught by industry leading experts. The program will provide
the training and the foundational information needed to properly control, document, and investigate foreign
particulate matter to ensure compliance with current good practices. This program will provide the perfect
balance of hands-on laboratory and lecture training, equipping you with tools and actual experience you can
apply immediately on the job.
Roy Cherris will lead you through the different stages of his life-cycle model to control foreign particulate matter
in parenteral drug formulations which support compliance to USP<790>. In stage one, you will learn to see
particles and document their physical appearance in the container. In stage two, you will learn techniques to
isolate the previously seen particles and their characterization with a microscope. You will also learn how to
document the physical appearance and include a digital image to the document.
Dr. Kathryn Lee, Dr. Olga Laskina and Dr. Oliver Valet will guide you through the collection of chemical evidence
by means of spectroscopy. To recognize the chemical structure and composition of a particle, several different
spectroscopic methods are necessary. In the training course, you will perform Raman, laser-induced breakdown
spectroscopy (LIBS) and FTIR / attenuated total reflectance (ATR)
spectroscopy on the individual particles.
Root cause investigation, sampling strategies, and
comparisons of the particle materials with sources
from manufacturing or packaging will be covered in
the training as well. Documentation is an integral
part of the control of foreign particulate matter,
so you will also learn the proper documentation
and interpretation of foreign particulate matter.
Who should attend?
Pharmaceutical, Biopharmaceutical
Development / Engineering / Manufacturing /
Packaging / Process Development / Quality
Technical Services / Validation
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Detailed workshop outline
Trainer: Roy T. Cherris, BAI / Kathryn Lee, PhD, rap.ID / Lin Bui, rap.ID / Olga Laskina, PhD, rap.ID /
Oliver Valet, PhD, rap.ID
Presented By
Time
Description
8:30am
Welcome
Dr. Oliver Valet
8:45AM
Introduction to Life Cycle Concept
Roy T. Cherris
What is Visual Inspection
9:30AM
Introduction to Workshop Concept
Dr. Oliver Valet
Workshop outline and Theoretical background
10:30AM
Break - Morning Tea
Tea, Coffee, Snacks
10:45AM
Hands On Part I
Various
Group 1: VI+PLM / Group 2: ISO / Group 3: FT-IR / Group 4: SPE
12:00AM
Hands on Part II
Various
Group 2: VI+PLM / Group 1: ISO / Group 4: FT-IR / Group 3: SPE
1:15PM
Break - Lunch
2:00PM
Hands on Part III
Various
Group 3: VI+PLM / Group 4: ISO / Group 1: FT-IR / Group 2: SPE
3:15PM
Hands on Part IV
Various
Group 4: VI+PLM / Group 3: ISO / Group 2: FT-IR / Group 1: SPE
4:30PM
Break - Afternoon Tea
Tea, Coffee, Snacks
4:45PM
Summary
Discussion, Documentation
5:30PM
Dr. Oliver Valet
Roy T. Cherris
Workshop End
Thank you
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About the Course Instructors
Roy T. Cherris
has been a Managing Partner with Bridge Associates International (BAI) since 1998
providing quality guidance and consulting for the Pharma and BioTech industries. His
primary focus is on visual inspection practices, particulate matter identification,
investigative microscopy, environmental monitoring, metrology systems and
microbiological control for parenteral, topical and solid dose products. He spent 24 years
with Hoechst Marion Roussel and Aventis Pharmaceuticals where he was the group
Manager of the Microbiology, Microscopy and the QA Metrology departments. He is
currently on the USP Expert panel for Visual Inspection and a key contributor for
developing USP<790> and USP<1790>. He holds a B.S. degree in Life Sciences with emphasis in Microbiology, as
well as advanced studies from the McCrone Research Institute in particulate analysis and microscopy.
Dr. Kathryn Lee
is the Lab Head for rap.ID Inc., the US branch of rap.ID GmbH, providing quality
instruments and lab analyses of particles in the Pharma and BioTech industries. Her
primary focus is on visual inspection and spectroscopic methods for particulate matter
identification. She has many years of experience working for pharmaceutical, consumer
product, and chemical companies. During this time, she established analytical methods for
solving product complaints, supporting global product and process development, quality
improvement, and developing and implementing innovative applications of new and
advanced spectroscopic analytical techniques, in compliance with ISO and cGMP. She is a
member of the American Chemical Society, PDA, and the Society for Applied Spectroscopy, where she has held
several leadership positions. She is holding a PhD degree in organic chemistry with emphasis on surface-enhanced
Raman spectroscopy.
Lin Bui
is the Laboratory and Service Engineer at rap.ID Inc.. He has had many years working in the
laboratory doing R&D, failure analysis, and Quality control. Before coming to rap.ID Inc.,
Lin provided laboratory support for Amgen, in California, servicing equipment for both
R&D and manufacturing. When not off site working with rap.ID customers, Lin works in
the laboratory developing methods and techniques to isolate particles and provide quality
analysis for rap.ID customers. He holds a Bachelor Degree in Biological Sciences from the
University of California in Irvine.
Dr. Olga Laskina
is an Application Scientist at rap.ID Inc. She provides extensive customer support and
advanced trainings on rap.ID instruments. She also develops new approaches and
methodologies for visible and sub-visible particles analysis using Raman and laser induced
breakdown spectroscopies. Before joining rap.ID Inc., Olga did PhD research studies of
chemical and physical properties of micro particles using IR and Raman spectroscopies. She
is a member of the American Chemical Society and an author of 14 publications including
six lead author papers.
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Dr. Oliver K. Valet
is co-founder of rap-ID Particle Systems GmbH which develops, manufactures and sells
rapid particle identification systems.
rap.ID's technology has combined particle isolation, imaging analysis and spectroscopic
technologies, creating investigative tools for particle identification and characterization.
Dr. Valet has extensive experience in foreign particulate matter testing and Root Cause
Investigation. He has also worked on the development of accurate and reproducible
technologies for characterizing silicone oil layer thicknesses and its distribution in
parenteral packaging materials.
Directions to rap.ID Inc.
Princeton Corporate Plaza
11 Deer Park Drive, Suite 201
Monmouth Junction, NJ 08852
Phone 732-823 -1567 / -1155
Deer Park Drive is between Raymond Rd. and Ridge Rd. on
Route 1 South. To get here, you must be going south on
Route 1. Turn right onto Deer Park Drive, which is the first
right, immediately past the Residence Inn sign. There is a
cement triangle with some plants that defines the
intersection of Deer Park Drive and Route 1 South, a small,
high, green street sign as well as a large Princeton Corporate Plaza sign.
Once you are on Deer Park Drive, turn left into the third driveway on the left which has a sign for building 7. Go all
the way to the end to building 11 on the right. The correct doorway is on the short side of the building, facing the
long driveway. We are on the second floor, near the front of the building, on the right as you exit the elevator, Suite
201.
Google maps is a little confused about where 11 Deer Park Drive is. If you put in 11 Deer Park Drive, Google maps
shows it much further down the street than it really is, but does show Insmed near where rap.ID is located Drive, in
a different, but more correct location.
How to register
Payment by Purchase Order
Amount
$475
Foreign Particulate Matter Control Stages Training, March 15th, 2016 - Monmouth Junction, NJ
Your Contact Information
Name, Job Title
Company, Mailing Address
Email, Business Phone
Date
Mandatory Signature
Please sign the document and email to: [email protected] or Fax: +1 732 823 -1697
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