This webinar will provide a detailed overview of cGMP regulations for IND drug and biologic products. The applicable requirements from earlier FDA guidance documents will also be addressed. The key differences between cGMP regulations between IND and manufacturing production will be identified to enable streamlining the drug development process through the identification of new, innovative therapies. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.

In conclusion, this webinar will educate the participant on the broad ranging systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.

Areas Covered in the Seminar:

- Key aspects of FDA cGMP requirements for IND products.
- Historical FDA cGMP requirements for drugs and biologics.
- Practical implications.
- Regulatory guidelines; FDA, ICH, CHMP, EMEA.


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