Impurities in APIs and Pharmaceutical Products
Current Regulatory Requirements

Date: 27 February 2019
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 19244
Course Language: Hebrew
About the Course
Impurities in active pharmaceutical ingredients (APIs) and in pharmaceutical products is a main issue reviewed both during the assessment of registration files (CTD) and during GMP inspections. Due to the importance and complexity of stability issues this subject is covered directly and indirectly by many regulatory guidelines. The objective of this course is to provide a comprehensive overview of the current approaches used to control impurities level in pharmaceuticals.
Who should attend
This course is suitable for any person involved in manufacturing, quality control, quality assurance, regulatory affairs, research and development and any other discipline that interfaces with manufacturing and control of pharmaceutical development or production.
Impurities in APIs and Pharmaceutical Products
Current Regulatory Requirements
Benefits to the Participants
At the end of this course participants will understand the regulatory basis for impurities control requirements.  Participants will be familiar with European and US FDA requirements and expectations.
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Issues to be covered
  • Classification of impurities
  • Characterization of impurities during the drug development process
  • Genotoxic impurities
  • Heavy metals impurities
  • Impurities in Generic Products
  • Detailed Review of ICH Impurity Guidelines
    • Q3A(R2) Impurities in New Drug Substances
    • Q3B(R2) Impurities in New Drug Products
  • Other ICH related guidelines
  • EU guidelines
  • FDA guidelines
About The Lecturer

Dr. Rachel Karpel

Dr. Rachel Karpel served for 12 years at the Israel Ministry of Health. In her last position, as the Director of the Institute for Standardization and Control of Pharmaceuticals at the Israeli Ministry of Health she was involved in policy making and oversight of the GMP Inspectorate, determining national policies regarding GMP and quality of pharmaceuticals as well as initiating the establishment of the Department for Quality Assessment of Biological Products at the Ministry of Health.
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Dr. Rami Kariv

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Dr. Uri Lerman

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