Setting Specifications for Drug Substances and Drug Products by Compliance4All

Setting Specifications for Drug Substances and Drug Products is organized by Compliance4All and will be held on May 23, 2018.

Overview:
This program will teach you to set specifications for drug substance and drug product, including use of release test data, long-term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management.

Why should you Attend:
Learn the recommendations of ICH for user testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Learn requirements for changing specifications 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
Updating the specifications during developing and commercial phases

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

Additional details will be posted as soon as they are available.