The recording of the free webinar which took place on 4th Jan 2023 is now available on demand. Click and watch the webinar about recent regulatory changes in analytical methods development and validation.
Upcoming Trainings
Trainings Calendar
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- 9Analytical strategy and method development (USA/Canada)
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- 21Analytical strategy and method development (Europe)
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- 23Analytical Methods Validation (USA/Canada)Validation of analytical methods is essential for their use in a controlled GMP, GLP environment. Appropriate design of validation tests and their performance underlie the effective work of laboratory teams and the reliability of results obtained.The online training “Analytical Method Validation” is address , ...
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- 28Analytical Methods Validation (Europe)
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- Quality by Design in Drug Products DevelopmentShare! Facebook LinkedIn Twitter Quality by design (QbD) is a concept that has become firmly established in the pharmaceutical and biotechnology world. The ICH, FDA and EMA have been working on the implementation of QbD in the life cycle of medicinal products for many years, resulting in the ICH Q8, Q9 and Q10 guidelines. However,…
- Fault Tree AnalysisRisk analysis is an integral part of working in the pharma and biotech industry. The ICH Q9 guideline describes exactly what it is used for and what risk analysis tools are proposed. Some of the most popular are FMEA, RRF, PHA, Ishigava diagram, HACCP etc. A few months ago, for a consulting project, I started…