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QbD Beyond Concepts: A Practical Implementation Plan

 
  May 23, 2013  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
July 10, 2013 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend
This course is intended to help pharmaceutical industry professionals understand and adopt Quality by Design (QbD) methods consistent with the emerging regulatory climate and the practical demands of the work environment. The course answers questions about where and when to start, what resources are needed and how to measure effectiveness. The Critical Circle icon in this course aids users in proportioning efforts between Risk Management, Knowledge Base and Application Interfaces as well as preparing for uncertainty. At the conclusion, participants will have a blueprint for QbD team operations, effective technology transfer and costs. It is intended for:

  • QbD project managers 
  • QbD team members 
  • New product developers 
  • Analytical scientists 
  • New product developers
  • Production managers 
  • Product financial planners 
  • In-process analysts 
  • Statistical process control users 
  • Unit operations staff

Description
This course will be available On Demand: July 11, 2013

This 90-minute accredited training course distills QbD concepts into a useful and relatively seamless effort within the confines of your existing company operations. The Critical Circle concept will help you launch the effort quickly while reducing uncertainty and missteps. Its modules show how to avoid “throwing the baby out with the bath water” mistakes that have hindered QbD adoption in the past. The course material is consistent with current FDA and EMA approaches.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: John E. Carroll, C.Ph.C., CEO, Carroll Brands, Director, Cadrai Group

John E. Carroll, C.Ph.C., is CEO of Carroll Brands and Director, Cadrai Group. The Cadrai Group develops and presents focused training programs for issues germane to the current needs of the pharmaceutical industry including small-molecule, biologic and nutraceutical preparations. Cadrai has an equally strong focus in both training and business development for the analytical instrument industry. Among Cadrai successes are: ion-mobility spectrometry for cleaning verification, NIR dedicated to tablet & capsule analysis, laser induced breakdown spectroscopy, chemical imaging and automated dissolution.

As Pharmaceutical Business Unit Manager for Perstorp Analytical Instruments (now Foss), Mr. Carroll built a global, sustainable business that saw over 8,000 NIR test instruments placed within the pharmaceutical manufacturing industry.

Mr. Carroll has a B.A.S in Engineering Technology/Chemistry, an M.B.A. (c) in International Marketing, sixty publications and numerous technical presentations. He is the author of “The NIR Desk Reference” (Carroll, He and Landa) and “The Handbook of FTIR” (Carroll). He is also the editor of “IR-MS: High sensitivity and selectivity for organic analysis” (Mattson and Carroll). Professional memberships include AAPS, ACS, CNIRS and ISPE.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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