Webinar Information


ICH Q11- API Manufacturing


ICH Q11- API Manufacturing, Aurora, Colorado, United States
Webinar Title
ICH Q11- API Manufacturing
Event Type
Webinar
Webinar Date
18-05-2018
Last Date for Applying
18-05-2018
Location
Aurora, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Manufacturing

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

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

 

Others Details

Know the aspects of development and manufacture of the drug substance, including steps to reduce impurities. Also get a clear idea about both traditional and enhanced approaches.

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months. $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
Training Doyens 26468 E Walker Dr,Aurora, Colorado  Pin/Zip Code : 80016-6104
Landmark
CO
Official Email ID
support@trainingdoyens.com
Contact
Training Doyens

Training Doyens 26468 E Walker Dr,Aurora, Colorado

support@trainingdoyens.com

   +1-720-996-1616
Armaya Smith

Training Doyens 26468 E Walker Dr,Aurora, Colorado

armaya.smith09@gmail.com

   +1-720-996-1616