Impurities in APIs and Pharmaceutical Products Current Regulatory Requirements

Expert Lecturer: Dr. Rachel Karpel
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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...Continue reading

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.

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Dates:  Coming soon.
The course will be scheduled based on the level of interest

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    Course location: Virtual Course
    Duration: 1-Day Course
    Hours: 10:00 - 14:00
    Credits: 1
    Course Language: עברית

    Course price: 471 £ + VAT

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