Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products (Biotech Training)
Venue: Online Event
|Event Date/Time: Aug 18, 2011||End Date/Time: Aug 18, 2011|
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.
Note :Add another webinar to your shopping cart and get 20% off on its price.