ِAnalytical Method Validation: From Lab to Compliance, Basic level

Wishlist Share
Share Course
Page Link
Share On Social Media

About Course

Course Language: Arabic / English

Pharmaceutical professional with over 15 years of hands-on experience in QC, R&D methodology and Formulation Development in the pharmaceutical manufacturing sector. Currently leading R&D initiatives while pursuing a PhD in Pharmaceutics at Cairo University. Passionate about bridging the gap between theory and practice through actual development projects, training and consulting. Noteworthy, holding a post graduate diploma from faculty of education (teaching methodology) enabled a great experience in training practice and consultations.Can support pharmacists, quality professionals, and manufacturers:* Adopt research- based industry approach.* Guide both generic and innovative product development.* Fine tune high quality pharmaceutical formulations.* Troubleshoot dissolution methods/ comparative dissolution studies for pharmaceutical products.* Troubleshoot HPLC methods for pharmaceutical analytes.* Solve real-world manufacturing challenges.* Advance their careers through practical, industry-focused training.* Design basic and advanced training programs for professional teams.* Consult innovative product development projects.

To reinforce technical depth, main reference materials — including ICH Q2(R2) and additional regulatory resources — are mentioned clearly to support further professional study and implementation.

Show More

What Will You Learn?

  • Each trainee should be able to:
  • Understand analytical method validation (AMV) as per ICH Q2.
  • Be familiar with the key references in AMV, globally (at least 3).
  • Adopt ICH guidelines as a basic reference.
  • Know the elements of AMV (at least the 4 essential characteristics).
  • Perceive the aim from each element of AMV.
  • Adopt the best practices in laboratory to achieve AMV.
  • Apply essential calculation using spreadsheet, specifically regression equation (for linearity).
  • Explain how to apply each element of AMV in the laboratory “FOCUSING ON HPLC METHOD”.

Course Content

Intro

Module 1: Introduction and late analytical method development
In this module we are building the mutual language based on the globally recognized ICH guidance and construct the mindset of laboratory professional that can connect systematically between the late stage of analytical method development and the launching of analytical method validation.

Module 2: Specificity and Range
In this module we dive in depth into the first 2 characteristics of analytical method validation, specificity and range, to illustrate the "know-how" based on the purpose and the meaning of both.

Module 3: Accuracy and Precision.
In this module we explained the detailed process of assuring accuracy and precision taking a practical example of a simple dosage form. We illustrated how to conduct the accuracy testing, in different 2 ways and how to go through the 3 levels of precision to assure that our method is precise and finally, we sum all up to illustrate the core benefit of the course, that we have a deep, but simplified, knowledge supporting your ability to validate a reliable method.

Analytical Method Validation Final Quiz

Earn a certificate

Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.

selected template

Student Ratings & Reviews

No Review Yet
No Review Yet

Notify Me When Live

Hiring Notification