| |
|
|
|
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
18-19 March 2013
Who Should Attend
This QbD course demonstrates the interaction of design space, knowledge basing, good analytical science and risk management with ICH Q2 principles, leading to successful analytical method validation. It is designed for:
• Pharmaceutical product developers
• Formulators
• Instrumental analysts
• Quality assurance scientists
• Product manufacturing managers
• Food scientists and managers Description
The course serves as a detailed overview of QbD, in its current evolution. Included are the tools needed to evaluate existing product manufacturing, assess QbD applicability and apply statistical process control to meet defined targets. The Critical Circle concept – zero-sum proportioning between Knowledge Base, Risk State and Desired State (key QbD aspects,) is applied to the Product Target Profile (PTP). A blend-uniformity case study serves as a proof-of-concept exercise. Course participants will evaluate the study and learn to adjust the Critical Circle accordingly.
The course content also includes a thorough grounding in Risk Management as defined and practiced in ICH Q9. The topics apply equally well to pharmaceutical, cosmetic, nutraceutical and food science applications.
|
|
|
|
|
|
|
|
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 smallmolecule, 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
|
|
|
|
|
|
|
|
|