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45 - PHR - Pharmaceutical Sciences

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	04 November 2024	5 Days	Istanbul	Registration Form Link
PHR 105	09 December 2024	5 Days	Istanbul	Registration Form Link

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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.

Course Details/Schedule

Day 1

Landscape of impurities requiring control in pharmaceutical products
General impurities: elemental impurities, residual solvents, microbiological
Drug-related impurities: process impurities, degradants, potentially genotoxic impurities

Day 2

Process Impurities
Understanding ICH Q3A
Where impurities originate
How impurities are characterized

Day 3

How specifications are developed
How impurities should be reported

Day 4

Degradants
Understanding ICH Q3B
Where degradants originate
How degradants are characterized

Day 5

Potential genotoxic impurities
How specifications are developed
How degradants should be reported

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SAHARA Group Training and Consultancy INC (in Turkish: SAHARA Group Eğitim ve Danışmanlık AŞ)

Tax Office: Beyoğlu (Istanbul/Turkiye,Tax No: 7390525151 (Vergi Dairesi: Beyoğlu (İstanbul), Vergi No: 7390525151)

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45 - PHR - Pharmaceutical Sciences

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

Course Description

Course Objectives

Who Should Attend?

Course Details/Schedule

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