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Drug Substances and Drug Products - Specifications

Event Details

Drug Substances and Drug Products - Specifications

Time: May 23, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Mar 15

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Event 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: support@compliance4All.com

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