Thursday September 2, 2010 Thursday September 2, 2010
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Interactive Workshop Sessions:
Dr. Carolyn Broughton
Scientist, Technology & Methods Management
Genentech |
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Carolyn Broughton, PhD, is currently a Scientist in Quality Control at Genentech, Inc. She has more than twenty years of experience managing microbiology laboratories in the biotechnology, pharmaceutical and cosmetics industries. She has authored articles for professional journals, presented at professional meetings, and provided training at laboratory courses. She received her PhD in Microbiology from North Carolina State University.
Mr. Robert F. Guardino, MS
Director of Microbiology
AAIPharma Inc. |
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Mr. Guardino is currently the Director of the Microbiology Lab for AAIPharma Inc. where he oversees a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostics products, and as a principal scientist during the development of PCR-based diagnostic products for a J&J Company.
Ms. Amy Karren, B.S. RM(NRM)
Microbiology Section Leader
Nelson Laboratories |
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Amy has been with Nelson Laboratories for 15 years. She serves as the microbiology section leader, overseeing bacterial endotoxin testing, microbial limits testing, standard plate counts, and microbial water testing. She is also trained as a Sterilization Specialist, which includes ethylene oxide, radiation, steam, and dry heat sterilization. She has implemented test systems for environmental monitoring, bacterial identifications, and biological indicator population verifications. She is a registered microbiologist (RM) with the American Association of Microbiologists.
She also serves on multiple working groups for the Sterilization Standards (TC198) and Biological Evaluation of Medical Devices (TC194) committees with the Association for the Advancement of Medical Instrumentation (AAMI). Amy is also a member of the Parental Drug Association (PDA), involved in writing technical reports for dry heat sterilization and environmental monitoring. She is serving on an ASTM committee for rubber products, specifically for medical gloves.
Amy has been a Certified Quality Auditor and a provisional RAB Lead Auditor. She also was a certified trainer for ISO 9001, 13485, and 17025 standards, including the requirements for RAB auditor training.
Amy received her degree in Biology, with emphasis in microbiology and chemistry from Utah State University. She also attended Humboldt State University to study marine biology.
Ms. Carolyn C. Phillips
Associate Director, Quality Control Quality Control Microbiology
Human Genome Sciences, Inc. |
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Ms. Phillips is a professional microbiologist and is Associate Director, Quality Control at Human Genome Sciences, Inc. HGS is a biopharmaceutical manufacturing company located in Rockville, Maryland. Her current responsibilities include leadership and management of HGS' corporate microbiology team and program.
Ms Phillips brings with her over 20 years of microbiological control and testing experience in the fields of biopharmaceuticals, biologics, pharmaceuticals and medical devices. She has worked as at Millipore Corporation, Dade Behring, Ethicon (a subsidiary of Johnson & Johnson), BioReliance Corporation and Human Genome Sciences. Her experience and interests include fill/finish aseptic processing, microbiological control of product, processes and facilities used in the production of API manufactured in microbial fermentation and mammalian cell culture processes, quality control and lot release testing of biopharmaceuticals and biologics, biocontamination control, adventitious agents testing (i.e. bioburden, sterility and mycoplasma); validation of facilities, equipment, sterilization processes, and test methods; and global harmonization of compendial microbiological tests.
Ms Phillips is currently a delegate representing the United States to the ad hoc committee, ISO TC 209 Working Group 2, for ISO 14698-1, 2 (Cleanrooms and Associated Environments - Biocontamination Control) and has provided external review and technical support to the USP ad hoc committee on Mycoplasma testing.
Mr. James R. Rickloff, M.S.
Partner / Principal Scientist
Advanced Barrier Concepts, Inc |
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James R. Rickloff is a Partner and Scientific Director for Advanced Barrier Concepts, Inc. in Cary, NC, which is in its' 14th year of operation. He holds a Master's Degree in Environmental Sciences and Engineering from Virginia Tech and obtained an in-depth sterilization background during a subsequent 12-year career at the American Sterilizer Company (AMSCO). His accomplishments include participating in the development of the VHP® Sterilization Technology and in demonstrating the effectiveness of hydrogen peroxide gas in decontaminating rooms, safety cabinets, and isolator systems in addition to obtaining several sterilization-related patents. Mr. Rickloff co-founded Advanced Barrier Concepts in 1994 to offer direct technical assistance to the pharmaceutical industry on the sterilization aspects and validation requirements for sterile isolator applications. He has given presentations on isolator decontamination issues at numerous conferences and seminars over the past 20 years.
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Dr. Jaspreet Singh Sidhu is currently VP Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. Prior to this position, Dr. Sidhu was Principal Scientist and Laboratory Research Director, and Senior Research Scientist for the University of Washington. Dr. Sidhu received his PhD in Biochemistry at the Brunel University and Max-Planck Institute for Biophysical Chemistry in Goettingen, Germany. He is a member of RAPS, PDA, and ISPE.
Mr. Mike Waddington
Vice President, Laboratory Operations
Accugenix |
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Michael Waddington co-founded Accugenix, a division of Acculab, Inc. in 1999, where he currently serves as Vice-President of Operations. Prior to joining Accugenix, Mr. Waddington served as Vice-President of MIDI Labs, Inc. and was Principal Investigator of the MicroSeq® Bacterial and Fungal Database Project.
In addition to working at Accugenix, Mike is also involved in other organizations as an invited speaker, guest lecturer and faculty member.
Mike received his B.S. degree in Microbiology from Virginia Polytechnic Institute and State University and his M.S. degree in Microbiology from the University of Delaware.
I. Phases of Drug Development &Validation Requirements:
II. Validation Requirements
III. Microbial Method Validation; Theory and Practice
IV. Interactive Exercise (As time and interest dictate)
Attendees will select a method to validate, and with the aid of validation templates, will devise a validation protocol. Attendees will work in pairs, and the partner will review and critique the validation protocol, and offer suggestions for improvement
V. Sample Dependent Method Selection- (Optional)
Microbial Enumeration Tests - An introduction to the new USP <61>
Interactive Session
Participants will evaluate "typical data" to determine the probable cause of a sterility failure.
Case Study Discussion
Accurate microbial identifications rely on a comprehensive and regularly updated database of DNA sequences representing known microorganisms. For optimal performance, these databases require addition of missing entries and updating of taxonomic name changes.
The focus of this presentation is to show how a regularly updated database will out-perform a commercially available database and public, user-contributed databases based on targeted, industry specific additions, and timely taxonomic updates.
Case Study Discussions:
Accuracy and Reproducibility of Microbial Identifications Based on Comparative DNA Sequencing: How Good Data Leads to Good Decisions
The ability to make difficult decisions about product integrity relies on accurate and reproducible data. Many companies have either released questionable product or discarded acceptable product based on poor information.
This presentation will illustrate several case studies of how companies could have made better-informed decisions had they utilized DNA sequence based results rather than phenotypic based results.
The aim of this workshop is to understand the importance of specified or objectionable organisms in Pharmaceutical products. The workshop will consist of a discussion around common issues with defining, determining, and testing for objectionable organisms. Do we have enough regulatory guidance on this subject from industry or our regulators currently?
A case study will be presented for the participants to work through using the information provided and generated during this presentation.
The course is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotech, and allied industries with responsibilities in the following areas:
Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $250.00 USD per person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
Hotel details will be post shortly.
For more information, please call us at 416-410-7402 or enquiry@ipacanada.com
