Conference Description:

Overview:
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:
Manufacturing
Supply Chain
Technical Operations
Quality Control
Quality Assurance
Regulatory Affairs

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]