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45 - PHR - Pharmaceutical Sciences

PHR 113 - Dissolution: Theory and Best Practices

Code	Start Date	Duration	Venue
PHR 113	14 October 2024	5 Days	Istanbul	Registration Form Link
PHR 113	18 November 2024	5 Days	Istanbul	Registration Form Link
PHR 113	23 December 2024	5 Days	Istanbul	Registration Form Link

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Course Description

This course provides focused, relevant instruction on the fundamentals of pharmaceutical dissolution testing as described in The U.S. Pharmacopeial Convention (USP). Participants in this course will gain an overview of the theory, practice, and history of dissolution. They will learn the practical aspects of conducting dissolution tests, best practices, and performance verification testing.

Course Objectives

Understanding the Compendial dissolution testing
Understanding USP’s perspective on dissolution through historical highlights
Understanding how PVT acceptance criteria are established
Understanding the Performance Verification Testing
Understanding the Best Practices

Who Should Attend?

Pharmacists
Chemists and laboratory technicians
Anyone who performs dissolution testing in the laboratory
QC and product development professionals who review dissolution data.

Course Details/Schedule

Day 1

Introduction to Dissolution
Historical aspects
Overview of Performance Verification Testing
Dissolution and the USP
Dissolution Theory

Day 2

Performance Verification Testing
ISO/cGMP considerations
Instrument Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
IQ/OQ/PQ for Apparatus 1, Apparatus 2, and associated equipment/vessls

Day 3

Practical considerations of PVT
Best Practices
Performance Verification Testing
Testing of USP Reference Standards

Day 4

General Dissolution Testing
Variables
Analyst training
Sample Preparation

Day 5

Importance of filtration
Device configuration
Pore size and distribution
Chemical compatibility, drug binding and extractables

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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 113 - Dissolution: Theory and Best Practices

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