New gdp's for medicinal products

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Drug Master Files under GDUFA

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Comparision of eu & indian gmp's

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Good distribution practices for API's

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New EMA Requirements for Excipient GMP's

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Patents & market exclusivity

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CGMP for IND phase I products

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Generic drug regulations for beginners.

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Product quality review

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Quality Risk management Application of FMEA

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Quality risk managment basic facilitation methods

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Quality risk management : Basic Content

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Real time release testing

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Generic Drugs User fee

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Process Validation for Beginners - FDA - EMA Approach

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Quality by Design : Design of experiments

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Quality by Design : Control strategy

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Quality by Design : Design Space

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