7–8 December 2015
City Convention Centre
Best practice in operation and validation of aseptic processes
Russell E. Madsen is President of The Williamsburg Group, LLC, providing expert pharmaceutical
consulting services including CGMP compliance, quality systems, aseptic processing and sterilization,
sterilizing filtration, design review, due diligence, and regulatory liaison. Prior to forming The
Williamsburg Group, he had served the PDA as Acting President and was Senior VP Science and
Technology. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director,
Technical Services, providing technical and general consulting services to Bristol-Myers Squibb
operations, worldwide. He is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, a
member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of
Parenterals Expert Panel, a member of Pharmaceutical Technology’s Editorial Advisory Board, and an
Honorary Member of PDA. He holds a Bachelor of Science degree from St. Lawrence University and a
Master of Science degree from Rensselaer Polytechnic Institute.
Marsha Stabler Hardiman has over 20 years of experience as a Microbiologist working in the
Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from
Western New England University in Springfield, MA. Marsha is a Senior Consultant for ValSource and
in this role helps companies implement quality risk management into their quality management systems
and validation programs. Marsha specializes in helping companies develop risk based environmental
monitoring programs. She also performs many training courses and webinars for aseptic processing,
cleanroom classification and facility start-up.
Marsha is an expert in pharmaceutical Microbiology test methods from Environmental Monitoring (EM)
and utility system microbial testing to intermediate product testing through final product sterility testing.
Marsha has also served as a Microbiology Expert - Notified Body regulatory inspector for CE
certification of medical devices and has extensive knowledge in quality systems. Over her career, Marsha has established
numerous EM programs for many different medical device and pharmaceutical companies. Marsha has extensive experience in
aseptic processing including process simulations for aseptically filled products. Marsha is active in industry and currently serves
on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB); is leading a
PDA Task Force on Microbial Investigations; is co-leader of the PDA Aging Facilities Analytics Task Force; serves on the PDA
Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting.
Course Details
Aseptic filling of parenterals is one of the most challenging tasks in pharmaceutical manufacturing and requires a thorough
understanding of a wide range of topics including sterile filtration, media fill and environmental monitoring. Strict control of these
aspects of processing is required to ensure product sterility, patient safety and compliance. These topics are also continually
influenced by new methods and innovations either process or technology wise.
This two-day seminar is designed to provide the latest in proven solutions in aseptic processing, and is intended to be beneficial
for both experienced individuals working with parenteral processing and those wishing to develop an understanding of the more
advanced considerations, whilst having the opportunity to learn and network with their more experienced peers. You will gain a
stronger understanding of the following:
Sterile filtration and the requirements for use and validation of Sterilising Filters
Best practice in Risk based Environmental Monitoring and expected updates to the ISO14644 standard
Aseptic Process Simulations and Intervention Risk Assessments
Who should Attend?
The seminar is appropriate for all personnel working in QA/QC, regulatory affairs, R&D, production, engineering, process
development, validation, and microbiology
How You Will Benefit?
At the conclusion of this session, participants will:
Further their understanding of aseptic processing specifically related to sterile filtration, media fill and environmental
Expand their awareness of hot topics and recent regulatory trends in this field
7-8 December 2015
City Convention Centre
Best practice in operation and validation of aseptic processes
Expand their industry network
Monday 7th & Tuesday 8th December 2015
City Convention Centre
Level 12, 300 Flinders Street
Melbourne, Victoria
See map
Welcome, Introduction and program overview
Session 1a - Risk Based Environmental Monitoring
Break for morning tea and Exhibitors
09:45am – 12:45pm
Session 2 - Introduction to New EM Risk Assessment Tool EM-REM (EMRisk Evaluation Model)
Questions and Answers – Sessions 1 & 2
12:45pm – 13:30pm
Lunch proudly sponsored by AMS
Session 3 – Risked based EM (cont)
Break for afternoon tea and Exhibitors
13:30pm – 17:00pm
Session 4a – Sterilizing Filtration of Pharmaceuticals and
Biopharmaceuticals: Structure and Function of Sterilizing Filters
Questions and Answers – Session 3 and 4a
17:00pm – 18:00pm
Networking proudly sponsored by Merck
Session 4b - Sterilizing Filtration of Pharmaceuticals and
Biopharmaceuticals: Correlation of Microbial Retention and Integrity Testing
08:30am – 12.30am
Break for morning tea and Exhibitors
Session 5 - Aseptic Processing Simulations
Questions and Answers – Session 4b and 5
12:20pm – 13:15pm
Lunch proudly sponsored by Laftech)
Session 6 – Intervention Risk Assessments
13:15pm – 16:30am
Break for afternoon tea and Exhibitors
Session 7 – Special Guest Speaker/Presentation
Questions and Answers – Session 6 and 7
Early Bird Rates
Concluding remarks and wrap up
ISPE/PDA Member: $800.00 incl GST - Non member: $1,050 incl GST
ISPE/PDA Member: $1000.00 incl GST - Non member: $1,250 incl GST
Registration fee includes all day catering and course material (supplied electronically)
Early Bird Discount ends on the 13h November at 5 pm
Click here to book online