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Site language : English - Français
Ref : 26778
Event :Drug Substances and Drug Products - Specifications

Date :Wednesday May 23rd, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

Drug Substances and Drug Products - Specifications Medicine - Pharmacy - Bio-Technologies - National Health - Management
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Everyone, Manufacturing Supply Chain Technical Operations Quality Control Quality Assurance Regulatory Affairs
50 1 --
English

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