Drug Substances and Drug Products – Specifications

Start Date : May 23, 2018
End Date : May 23, 2018
Time : 10:00 am to11:30 am

Phone : 18004479407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

Website

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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