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Workshop - Validation of Analytical Methods for FDA and EU Compliance
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 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. |
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| URL from this website: |
http://www.analyticavietnam.com/en/Home/conferenceprogram/workshop |
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