Virus Clearance

מרצה: Mr Mark Trotter

תאריך: 29 נובמבר 2018
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,350 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 18472
שפת הקורס: אנגלית
על הקורס

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

קהל היעד

  • Process Development
  • Research & Development Scientists
  • Quality Control and Regulatory Affairs Personnel
התועלת שתופק

At the completion of this workshop the participant will be able to:

  • Understand virus safety for biologicals, biopharmaceuticals.
    • Know methods for detecting viral contamination, PCR, CPE, TEM.
    • Understand new methods for virus inactivation / removal technologies.
    • Discuss current industry perspective on virus validation studies.
    • Interpret virus clearance results from infectivity studies
    • Gain a better understanding of terminology used.
    • Know current regulatory guidance and industry standards and trends
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

This course 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.
PREREQUISITES: Basic understanding of life science and microbiology.  

אודות המרצה

Mr Mark Trotter

A. Mark Trotter, MS, MBA,
with over twenty-five years experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory & process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.
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