This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies.
Why should you Attend:
Learn the recommendations of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Learn requirements for changing specifiations through the lifestyle of the product.
Areas Covered in the Session:
Setting intial specifications
How to use available data and justify spectifications
ICH specific recommendations will be discussed
Informaton required to br submitted during the lifecycle
Who Will Benefit:
Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
Event Fee: One Dial-in One Attendee Price: US$150.00
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