Analytical Data at the Service of the Regulatory, Formulation and QA Staff

נתונים אנליטיים בשרות אנשי רגולציה, פורמולטורים והבטחת האיכות
מרצה: Dr. Malcolm Ross

תאריך: 22, 23 יולי 2012
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: 2
מק''ט: 12229
שפת הקורס: עברית
על הקורס

Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory

קהל היעד
Staff who use analytical data but are not trained as analytical chemists:
  • Formulators
  • Quality Assurance and Q.P. staff who have not come through the QC route
  • Regulatory Staff who handle analytical data in making submissions
Analytical Data at the Service of the Regulatory,  Formulation and QA Staff
התועלת שתופק
  • A fundamental understanding of analytical chemistry with particular regard to the confidence level of results in terms of the different techniques available
  • The ability to review the quality of the data generated and the suitability of different analytical techniques in answering the questions that are asked throughout the process of development, production and registration
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • A brief overview of the historical development of pharmaceutical analysis questioning whether analytical chemistry has become more precise. The difference between absolute and comparative techniques will be discussed. The use of reference standards and their qualification will be included.
  • The use of qualitative [identification] and limit tests and their difference from quantitative techniques in terms of execution and validation will be considered.
  • The relationship between precision and selectivity and how modern techniques such as HPLC have high selectivity at the expense of precision.
  • Sources of error in basic methodology will be considered including the incorrect use of laboratory glass ware as a major source of error.
  • The principles of method validation with particular reference to chromatographic methods and some of the problems involved in validation such as setting minimum detection limits will be detailed. 
  • The ICH guidelines and concepts of precision, accuracy, robustness etc. will be discussed.
  • Some of the problems met whilst generating stability data will be considered.
  • A specific section will be devoted to issues surrounding the use of HPLC and the difficulty of interpreting chromatograms will be illustrated.
  • A review of performance tests related to formulations will be included [dissolution, disintegration etc.]
  • Finally some of the basic principles of Good Laboratory Practice will be considered and out of specification [OOS] investigations will be reviewed
אודות המרצה

Dr. Malcolm Ross

Dr. Malcolm Ross is a consultant specialising in training, project management and research and development in the pharmaceutical industry.
He holds a B.Pharm and Ph.D in medicinal chemistry from London University, was a lecturer at the Welsh School of Pharmacy, UWIST and a Visiting Senior Lecturer in the Dept. of Chemistry at Bar Ilan University and is a registered pharmacist in the State of Israel.
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