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45 - PHR - Pharmaceutical Sciences

PHR 101 - Reference Standards: Characterization, Use and Handling in Pharmaceutical Analysis

Code Start Date Duration Venue
PHR 101 24 June 2024 5 Days Istanbul Registration Form Link
PHR 101 29 July 2024 5 Days Istanbul Registration Form Link
PHR 101 02 September 2024 5 Days Istanbul Registration Form Link
PHR 101 07 October 2024 5 Days Istanbul Registration Form Link
PHR 101 11 November 2024 5 Days Istanbul Registration Form Link
PHR 101 16 December 2024 5 Days Istanbul Registration Form Link
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Course Description

The establishment, handling and use of reference standards is a key issue for analysts in every quality control laboratory in the pharmaceutical industry because the ability to demonstrate compliance of pharmaceutical  products with the original license approval conditions depends on the accuracy of the analytical results. Therefore the integrity of the reference material is pivotal to  the consistency of all analytical determinations. The application of reference standards is provided for in many monographs of the various pharmacopoeias as well as in internal test procedures for finished products.

Detailed topics such as the novel nature of traceability and thus the employment of multiple certification conventions such as utilizing consensus values from inter-laboratory collaborations for validity purposes and similar concepts that require analytical solutions will be imparted for the purposes of equipping the delegate with off the cuff strategies to be employed for efficient and yielding research.

Course Objectives

  • Gaining a thorough acquaintance with the expansive scope of the reference materials in pharmaceutical applications
  • Familiarizing the delegate with the terminology
  • Explaining classification systems for both compendial and non-compendial reference standards
  • Learning the appropriate methods and standards for their utility 

Who Should Attend?

  • Industrial pharmacists, scientists, regulators, and researchers, who perform analytical testing or manage an analytical laboratory for pharmaceutical analyses
  • Health managers
  • Doctors
  • Pharmacists
  • Anyone who is involved in pharmaceutical analysis

Course Details/Schedule

Day 1

  • Terms and definition of reference standards
  • Importance of reference standards
  • Their use in pharmaceutical analysis
  • Classification of reference standards

Day 2

  • Qualitative analysis 
  • Quantitative analysis 
  • Specific use 

Day 3

  • Types of standards used for equipment calibration and qualification
  • Method validation 
  • Uncertainty of method 
  • Analytical Reference Standard 

Day 4

  • Working Standards 
  • Working Standards Preparation 
  • Characterization of Reference Standards 
  • Requirements for characterization

Day 5

  • Correct use of Pharmacopeial CRSs.
  • Traceability of standard materials
  • Auditing related to reference materials in analytical control laboratories.