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Site language : English - Français
Ref : 27119
Event :ICH Q11- API Manufacturing

Date :Friday May 18th, 2018

Location :Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

 

OVERVIEW

This program will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.

WHY SHOULD YOU ATTEND

This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing.

AREAS COVERED

  • Manufacturing process development
  • Process controls
  • Selection of starting materials
  • Control strategy
  • Process validation evaluation
  • Submission of information
  • Life cycle management

LEARNING OBJECTIVES

By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements.

WHO WILL BENEFIT

  • Quality Assurance
  • Quality Control (Chem and Micro)
  • Process and Design Engineering
  • Process Automation
  • Manufacturing Operations
  • Validation
  • Utility Operations
  • Regulatory Affairs

For more detail please click on this below link:

https://bit.ly/2IYbQFR

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616         

Fax: +1-888-909-1882

 


Location

Map and directions
Conference address :
Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora
United States
tel : 7209961616
Map and directions

Further information

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Details

ICH Q11- API Manufacturing Pharmacy
understanding the manufacturing process for a drug, api manufacturing
Professionals
50 1 --
English

Other

For more information on ICH Q11- API Manufacturing, plsase contactr Training Doyens

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