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45 - PHR - Pharmaceutical Sciences

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PHR 105 - Control of Drug-related Impurities, Degradants and Potential Toxic Impurities in Drug Substance and Drug Product

Code	Start Date	Duration	Venue
PHR 105	22 April 2024	5 Days	Istanbul	Registration Form Link
PHR 105	13 May 2024	5 Days	Istanbul	Registration Form Link
PHR 105	24 June 2024	5 Days	Istanbul	Registration Form Link
PHR 105	22 July 2024	5 Days	Istanbul	Registration Form Link
PHR 105	26 August 2024	5 Days	Istanbul	Registration Form Link
PHR 105	30 September 2024	5 Days	Istanbul	Registration Form Link
PHR 105	04 November 2024	5 Days	Istanbul	Registration Form Link
PHR 105	09 December 2024	5 Days	Istanbul	Registration Form Link

 

Course Description

The control of drug-related impurities can be the source of much anxiety, including the establishment of specifications and during release and stability testing of subsequent samples. This course will help participants to understand the expectations, and give practical advice for setting specifications and for addressing issues during routine testing.

Course Objectives

• Understanding what specifications will conform to regulatory expectations
• Developing an process for reporting impurities and addressing OOS situations
• Understanding regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals

Who Should Attend?

• Chemists
• Supervisors
• Laboratory Managers (Research, Quality Control, CRO)
• Quality Assurance personnel involved with generating reporting impurity results
• Regulatory affairs/CMC personnel responsible for documenting compliance with impurity requirements.