Stability Testing Of Pharmaceutical Products From Regulatory Perspective

This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.

Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements.

Also, they will be able to determine the types and conditions of stability testing required for different types of pharmaceutical products.

During the webinar, we will discuss all factors that are inherent to the stability testing and that any changes to these factors post-approval will lead to repeating the stability testing for variation approval.

Webinar Jan 01 2026, Thursday 12:00 PM EDT 60 Minutes Intermediate Level Code: GRC0000282

  • The purpose of performing stability testing in the pharmaceutical industry
  • Factors affecting the stability of pharmaceutical products
  • ICH climatic zones
  • ICH requirements for stability testing
  • Different types of stability testing and when it is required
  • Developing stability testing protocol
  • Most common inquiries raised by the reviewers regarding the stability of data
  • Recommended labeling statements for storage conditions

  • Stability Personnel
  • Methodology Personnel
  • Quality Control Personnel
  • Product Development Personnel
  • Regulatory Affairs Personnel

  • To be aware of the purpose and objective of performing the stability testing
  • To be aware of the regulatory guidelines that regulate the stability testing
  • To know different types of stability testing
  • To know how to determine the storage conditions and its relevant labeling statement  
  • To understand what stability testing is required following changes to a product
  • To know how to place the stability results in the submission

MOHAMMAD ELNADI
MOHAMMAD ELNADI
20 Years

Mohammad is a highly accomplished pharmaceutical professional with over 20 years of experience in the pharmaceutical industry, specializing in business development, regulatory affairs, supply chain management, and international training. As a co-founder of the Arab Pharma Experts Association (APEA), Mohammad has established himself as a trusted expert in the field, combining his deep regulatory knowledge with strong business acumen to drive success in both local and international markets.
Mohammad began his career after earning a bachelor’s degree in Pharmaceutical Science from the University of Cairo in 2005. He quickly gained hands-on experience in research and development (R&D) and production of pharmaceutical dosage forms, as well as in coordinating contract manufacturing activities. His passion for continuous learning led him to pursue a postgraduate certificate in management from the American University in Cairo (AUC), where he honed his skills in marketing, project management, finance, and organizational behavior. Over the years, Mohammad has held several senior management roles, including Business Development Senior Officer, Supply Chain Manager, and Product development project manager at Elrazy Pharmaceuticals Co. In these positions, he successfully led market access projects, negotiated deals with overseas agents, and established supply chain strategies that aligned with the company’s overall goals. His efforts have enabled Elrazy Pharmaceuticals to expand its presence in key markets across Africa, ASEAN, and the GCC regions.In addition to his corporate roles, Mohammad has served as an independent pharmaceutical consultant and trainer, working with organizations such as IPI Academy in London and Pharmastate Academy in Delhi. He has delivered a wide range of training courses on topics such as Regulatory landscape, regulatory project management, supply chain optimization, and risk management. His expertise has benefited professionals from leading pharmaceutical companies across Egypt, UAE, KSA, Sudan, Spain, Portugal, Sweden & beyond.Mohammad’s extensive experience also includes roles as Managing Director of REYADA PRO for pharmaceutical services and consultancy, where he provided strategic guidance to clients, and as Regulatory Business Development Manager at REG EXPERTS, where he helped companies navigate complex regulatory landscapes. His ability to bridge the gap between regulatory compliance and business strategy has made him a sought-after expert in the industry. As an international trainer, Mohammad has conducted numerous online and offline courses, sharing his knowledge with professionals from diverse geographical regions. His training programs cover critical areas such as MENA region guidelines for drug registration, pharmaceutical supply chain management, and product development. His practical approach and real-world insights have earned him a reputation as a dynamic and engaging trainer. Mohammad’s educational background is complemented by a wide range of professional certifications, including Lean Green Belt, QMS Lead Auditor ISO 9001, and a Data Analytics Nanodegree from Udacity. He is also a certified business analyst and has completed advanced courses in strategic marketing, communication skills, and problem-solving. With a proven track record of driving cost efficiency, regulatory compliance, and market expansion, Mohammad continues to make significant contributions to the pharmaceutical industry. His unique blend of regulatory expertise, business development skills, and training capabilities positions him as a key player in shaping the future of pharmaceutical manufacturing and supply chain management.

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