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Home Pharma Courses Advanced Regulatory Affairs Training – focus on CMC/Quality Part
Impurities and Degradation in Drug Products SAR  4,800
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Pharmacovigilance for QPPV SAR  4,370
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Advanced Regulatory Affairs Training – focus on CMC/Quality Part

SAR  4,800

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Category: Pharma Courses
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Description

Learning Objectives:

 

After completing this 2-days training course, participants will be able to:

  • Understand different types of API submissions (DMF, CEP or Complete 3.2.S).
  • Identify documentations required for API and FPP manufacturing processes including API general properties, API & FPP manufacturing process and controls, studies conducted to identify API chemical structure as well as potential API polymorphic forms and process validation requirements for both API & FPP.
  • Recognize API and FPP potential and actual impurities (organic, inorganic, genotoxic impurities, degradation products, residual solvents, and heavy metals) and comprehend their possible control strategies.
  • Understand how to Set API & FPP specifications & analytical procedures as well as validation of these analytical procedures.
  • Define the Requirements on container closure system and stability data for both API & FPP.
  • Make use of references to assess the appropriateness of eCTD documentations (e,g, SFDA guidelines, ICH guidelines, Pharmacopeias, USFDA & EMA related guidelines)
Additional information
Date

1 & 2 March 2023

Location

Riyadh – Saudi Arabia

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  • Location: Saudi Arabia, Reyad.
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  • Email
    info@mesned.com
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