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Strategies for Leveraging PAT/QbD in Biologic Applications

  February 19, 2009  
The Center for Professional Advancement, 90 Minute Accredited Online Training
April 2, 2009 at 11:00 a.m. - 12:30 p.m. (EST)

Who Should Attend
This course is intended to help biologic and biosimilar professionals charged with enhancing and improving manufacturing efficiency for existing drug products (PAT) and those who are developing new drugs according to USFDA and EMEA product life cycle initiatives (QbD). The concepts presented in this course can establish a blueprint for QRM team formation, cost vs. benefit decision tools and guidance toward the most effective unit operations for PAT/QbD enhancement. It is intended for:

  • PAT/QbD Program team members 
  • Tech transfer personnel
  • Purification, separation, pooling and yield staff
  • Quality program managers
  • Operations and process control personnel
  • Production managers
  • Fill & finish staff 
  • Product financial planners
  • Function cross-over personnel 
  • New product planners and developers
  • In-process analysts 
  • Product release analysts

This 90-minute accredited training course provides critical decision-making tools, from inoculation and transfer issues through predictive operation control to product release, fill and finish -and patient use. The three modules include an overall exploration of the current QRM climate, benchmarking tools, strategies for technology transfer and smooth regulatory interaction.

Module 1:
  • Quality Risk Management embraces both PAT and QbD
  • Product and process optimization
  • Identifying CQA's and CPP's
  • Benchmarking with risk assessment tools

Module 2:
  • Using batch history in process optimization
  • Inferential and first-order analyzers
  • The value of factorial and multivariate analysis
  • RPN and documenting: the seeds of technology transfer

Module 3:
  • Managing the program
  • Training operators: a case for hands-on OJT
  • Taking the next steps: PAT leads to QbD, both lead to 
    SPC and EVOP
  • Interfacing with the regulators and regulations

Question and Answer Session

Organized by: The Center for Professional Advancement
Invited Speakers: John E. Carroll, C.Ph.C., President, Carroll Ventures, Inc., Managing Partner, Cadrai Technology Group

John E. Carroll is Managing Partner, Cadrai Technology Group and President, Carroll Ventures, Inc. The Cadrai Technology 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, laserinduced 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: salbers@cfpa.com
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