2018 - Drug Substances and Drug Products - Specifications

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: support-AT-compliance4All.com