Biography

About the Instructor

Mohamed Khidr Arafa is the R&D Methodology & Stability Section Head and New Products Project Manager with over 13 years of experience in pharmaceutical research and development. He specializes in analytical method development, validation, method transfer, and stability studies across multiple pharmaceutical dosage forms. Mohamed has extensive expertise in regulatory compliance, preparing CTD, CADC, stability, and bioequivalence files, and managing projects in alignment with international standards including EDA, FDA, USP, BP, EP, JP, IP, ICH, WHO, and EMA.

At Atco Pharma, Mohamed leads the Methodology and Stability team, supervises pre-audit and internal audit processes, and mentors staff on analytical techniques, stability assessments, and regulatory documentation. His courses are highly practical, focusing on bridging scientific knowledge with real-world R&D applications, helping learners develop robust skills in method development, stability testing, and quality systems.

Education

• MSc in Quality Management, Arab Academy for Science, Technology & Maritime Transport, Egypt (2024)

• Diploma in Analytical Biochemistry, Minufea University, Egypt

• Diploma in Analytical Biochemistry, Mansoura University, Egypt

Professional Experience

• R&D Methodology & Stability Section Head / New Products Project Manager – Atco Pharma (2014 – Present)

• Methodology & Stability Senior – SAJA Pharmaceuticals (2014)

• QC Specialist – Pfizer (2014)

• QC Specialist – SABAA Pharmaceuticals (2010 – 2014)

Areas of Expertise

• Analytical Method Development, Validation & Transfer

• Stability Studies & Pre-Formulation Support

• Regulatory Compliance (EDA, FDA, USP, ICH, EMA, WHO)

• Project Management & New Product Development

• Internal Audits, SOPs, and Documentation

• Team Leadership, Mentoring & Staff Training

• Risk Assessment & Problem Solving in R&D

Academic & Industry Contributions

• Led the development and validation of analytical methods for multiple pharmaceutical products

• Prepared regulatory dossiers for national and international submissions

• Supervised and trained R&D teams on methodology, stability, and quality systems

• Conducted workshops and training programs to improve analytical skills and regulatory understanding

Courses

Basics of Method Development

1h 22m

By Mohamed khedr In Research and Development R&D

999 EGP

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