Qualification of impurities, leachables, extractables
Residual solvents and excipients

מרצה: Dr. Shayne Gad

תאריך: יפורסם בהמשך
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 17801
שפת הקורס: אנגלית
על הקורס

Learn how to

  1. Obtain and draw structure
  2. Use a structure to find toxicity data
  3. Use various regulatory guidelines to evaluate a compound (ICHQ3A/B/C/D, ICH M7)
  4. Implement risk assessment and qualification methods
  5. Qualify impurities, degradants, residual solvents, leachables, extractables, and excipients
  6. Select and use surrogate compounds for evaluation


  • General considerations for drug packaging and medical device leachables and extractables
  • Overview of (Q)SAR methods and systems
קהל היעד

In this workshop we draw on popular internationally accepted risk assessment methods. Learn what methods your competitors are using to get their products approved.

  • Toxicologists, Pharmacologists, Pathologists, Biologists working in Academics, Government and Industry
  • Study Directors conducting Pre-clinical studies
  • Those who wish to become Study Directors in Pre-clinical studies
  • All the scientific/study personnel working in Pre-clinical GLP studies
  • Those who wish to take the DABT exam and all of those who will be giving recertification exam for the DABT
  • Regulatory staff (DCGI, CIB, OECD etc) handling Pre-clinical studies
  • Government GLP study monitoring staff
  • All veterinary staff involved in animal welfare, handling and maintenance of vivarium in GLP toxicology facilities
  • Academic community who teach Toxicology
  • Government Scientific Institutes and private laboratories who support Pre-clinical GLP studies  

Qualification of impurities, leachables, extractables
Residual solvents and excipients
התועלת שתופק
יפורסם בהמשך
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Introduction to efficient and cost effective qualification of impurities, residual solvents, excipients, leachables and extractables: Hierarchical approaches
  • Introduction and Overview of (Q)SAR Methods & Application
  • How to Search for a Structure or Compound and Find Toxicity Data
  • Tools
  • Use of (Q)SAR Methods & Systems
  • TTC and M7
  • Review of Pharmaceutical Guidelines for Impurities, Degradants, Residual Solvents, Elements
  • Risk Assessment and Qualification Methods for Impurities, Degradants, Residual Solvents and Leachables and Extractables
  • Selection of Uncertainty Factors
  • Qualifying Excipients
  • Use of Surrogate Compounds in Risk Assessment
  • Drug Packaging and Medical Device: Extractable and Leachable Considerations and Challenges
  • Case Studies
  • Questions, Review of Testing Labs
אודות המרצה

Dr. Shayne Gad

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. (U of T at Austin, Pharmacology/Toxicology, 1977), DABT, is the principal of Gad Consulting Services, a twenty-eight year old consulting firm with ten employees and more than 600 clients in the US and overseas.
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