At the second show day, the workshop "Validation of Analytical Methods for FDA and EU Compliance" held by Dr. Ludwig Huber took place at the Meeting Room 4 of the Saigon Exhibition and Convention Centre.

The workshop was dedicated to senior analysts and laboratory Management of (bio)pharmaceutical and food laboratories.








Contents overview:

• FDA/EU, ICH, USP and ISO 17025 requirements and inspection practices
• Developing a validation plan and protocol in line with regulatory and quality standard requirements
• Define the scope of methods, validation parameters and acceptance criteria
• Prerequisits for method validation: SOP‘s, qualified instruments and qualified of materials
• Design experiments for 9 validation parameters
• Statistical evaluation of validation results for: precision, intermediate precision, linearity, reproducibility, limit of detection, limit of quantitation, robustness, specificity and range
• Recommendations what, when and how to revalidate after changes
• Transfer of analytical methods
• Verification of standard and compendial methods 
• Development and validation of stability indicating methods
• Preparing validation reports in line with regulations and quality standards

Please find here some further information on the workshop.