Validation and Verification of Analytical Methods – in Pharma & Medical Devices
Gstudy > Courses and seminars > Validation and Verification of Analytical Methods – in Pharma & Medical Devices
Quality Assurance
Pre Clinical Studies
Location: Frontal
Starts at: 09:30
Duration: 1 Session
Language: Hebrew
Validation and Verification of Analytical Methods Professional Training
This seminar provides comprehensive training on analytical methods with a focus on their validation and verification, aligned with ICH Q2/Q7 guidelines and key pharmacopoeial chapters (<1224>, <1225>, <1226>). Participants will learn about method characteristics, acceptance criteria, protocol and report writing, and regulatory expectations.Why Take This Course?
The course goes beyond theory to deliver practical insights into method validation, illustrated with real-life case studies and examples for each validation parameter: specificity, linearity and range, accuracy, precision, LOD & LOQ, robustness, and solution stability. Participants will leave with the skills needed to confidently design, perform, and evaluate analytical method validation and verification processes.Who Should Attend?
- Analytical laboratory staff and R&D personnel
- QA staff and laboratory managers
- Professionals in pharmaceutical companies and medical device manufacturers that apply analytical methods in testing
- Organizations with laboratories operating under GMP-like conditions (e.g., pharma-like setups in medical devices)
Basic Requirements
Laboratory staff with at least one year of experience.Course Topics
- Regulatory requirements: ICH Q2/Q7, pharmacopoeial chapters (<1224>, <1225>, <1226>)
- Structure of analytical procedures and chromatography basics
- System Suitability Test (SST) acceptance criteria
- Validation parameters: specificity, linearity, accuracy, precision, LOD & LOQ, robustness, stability
- Protocol and report writing for validation and verification
- Practical examples and case studies
When: 13/05/26
9:30-15:30 Gstudy Training Center HaifaAbout Anat Sokol, M.Sc
Anat Sokol holds a Master’s degree in Industrial Chemistry and brings over 15 years of experience in the pharmaceutical industry, with a strong foundation in analytical laboratories, method validation, lab investigations, and quality system improvement. In her leadership roles at companies such as Omrix and Teva, she managed laboratory teams, led stability studies, cleaning validation projects, authored analytical protocols and...
Contact Us
Thank you for registering to the course!
We will contact you soon in order to complete the registration procces.
In the meantime, the course details have been emailed to you.
Comments
Master the critical regulatory requirements and technical expertise essential for analytical method validation in pharmaceutical manufacturing. This comprehensive one-day seminar provides regulatory professionals with practical knowledge of ICH Q2/Q7 guidelines, pharmacopeia standards, and validation parameters across all test categories.
Registration Information
Contact: Gstudy@gsap.co.il