Welcome To Mesned Pharma Consult Center

Address: Al Hawiy St., Hitteen Dist., Riyadh , Saudi Arabia

P.O.Box: 13516

Phone: +966920019011

Mobile: +966532375500

Consultation Email: info@mesned.com

Training Email: training@mesned.com

CRO Email: cro@mesned.com

Pharmacovigilance Email: bd@mesned.com

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Course Details

Advanced Regulatory Affairs Training – focus on CMC/Quality Part

Advanced Regulatory Affairs Training – focus on CMC/Quality Part

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)


bana

 MPCC (a member of Bana Group) was established in 2005 and is now the healthcare industry’s FIRST choice for sustainable outsourcing of Regulatory affairs, Clinical Research and Technical consulting services in the Middle East.