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Hotel Information
Hyatt Regency New Brunswick
Limited rooms are available at the group rate until August 30th. To make resevartion go to link below or contact the hotel.
https://resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventID=2614992
Phone: 800.233.1234
Code: Global BioPharmaceutical Resources
Group Rate: $145
Registration Fee
Before September 1: $695
After September 1: $995
DESCRIPTION
This program covers basic theory and practical applications for the removal / inactivation of virus contamination in biopharmaceuticals and biological materials. The course format is a combination of lecture and discussion experiences. Various orthogonal methods of viral inactivation/removal will be discussed which includes chromatography, inactivation technologies, e.g., UVC, Solvent/Detergent, and Nanofiltration. Course attendees will come away with a solid background and understanding of these methodologies, terminology, risk assessment and current regulatory and industry trends.
RATIONALE
Cell line characterization, raw material testing and validation are core concepts for the removal / reduction of any potential viral contaminants from the manufacturing processes and drug / therapeutic product. These are necessary consideration to ensure viral removal and product safety as required by regulatory guidance and industry standards.
Who Should Attend
Process Development, R&D Engineers and Scientists, Quality Control and Regulatory Affairs Personnel.
PREREQUISITES
Basic understanding of life science and microbiology (helpful)
Learning Objective
At the completion of this workshop the participant will be able to:
• Gain a better understanding of terminology used.
• Distinguish viral types, RNA-DNA, and review nomenclature.
• Understand virus safety for biologicals, biopharmaceuticals.
• Know methods for detecting viral contamination, PCR, CPE, TEM.
• Understand new methods for virus inactivation / removal technologies.
• Determine methods and robustness to achieve LRV in process.
• Discuss current industry perspective on virus validation studies.
• Know current regulatory guidance and industry standards and trends.
Presenter
Mark A. Trotter, MSc., MBA
Trotter Biotech Solutions
About Presenter
A. Mark Trotter, MSc., MBA, Owner and Principal Consultant , Trotter Biotech Solutions
Mr. Trotter, owner and principal consultant of Trotter Biotech Solutions, a consulting and training organization, supports the on-going technology transfer and training programs in the pharmaceutical, biologics, & bioprocessing industries.
He completed his post-graduate studies at Long Island University, NY, earning his MS in Medical Microbiology and continuing to earn his MBA in Finance. He has specialized training and work experiences in membrane technologies, including sterilizing, prefiltration, chromatography and single-use disposables technologies. Upstream fermentation to downstream applications including separations, clarification and purifications processes technologies are subject matter expertise he uses for training, technology transfer and consulting.
Mr. Trotter has an extensive background in the biopharmaceutical sciences coupled with regulatory knowledge that support his expertise in process validations. Mr. Trotter, with over twenty-five years experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry academic research project leader to marketing management in the laboratory & process equipment industries.
Mr. Trotter has published numerous technical articles, book chapters and contributed expert editorial comment on these subjects. He is a member of PDA (Parenteral Drug Association) ASM (American Society of Microbiology) Society for Biological Engineering (AIChE), International Society for Pharmaceutical Engineering, (ISPE.), and the Society of Biological Engineering (SBE.) Mr. Trotter actively participates on various technical committees and presents papers at society meetings and for interest groups. |
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