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Current Industry Trends and Rethinking on QbD

  November 03, 2014  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
15-16 April 2015

Who Should Attend
This QbD course demonstrates the interaction of design space, knowledge basing, good analytical science and risk management with analytical methods, especially those that use modern instruments. It is designed for:

  • Pharmaceutical product developers
  • Formulation scientists
  • Real-time release test personnel
  • Instrumental analysts 
  • Quality assurance scientists
  • Product manufacturing managers
  • Laboratory managers
  • Food scientists and managers

The course serves as a detailed overview of QbD, focused on current, state-of-the-art Analytical Methods as the target “Desired State.” The Critical Circle concept – zero-sum proportioning between Knowledge Base, Risk State and Desired State (key QbD aspects,) is applied to three principal instrumental methods. Manufacturing QbD aims at a Product Target Profile (PTP). For analytical methods, the Desired State becomes an Analytical Target Profile (ATP.) Course participants will evaluate both pathways 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: Janet Bowen; Vice President, CAI Consulting

Janet Bowen, Vice President, CAI Consulting, is experienced in Quality Systems, Manufacturing Excellence, and US and Foreign GMP Compliance Professional with more than thirty year’s experience in the Pharmaceutical, Biotechnology, and Device manufacturing industries. She has significant experience in Compliance and QA management, Validation, and GMP compliance auditing of manufacturing facilities for production of sterile products by aseptic processing, solid dosage forms and other external forms, APIs made by biotechnology or chemical synthesis, clinical trial materials and medical device distribution and manufacturing. Additionally, Ms. Bowen has considerable experience with contract manufacturing where products, test methods, and in some cases specific instruments were developed at the owner’s site and transferred to the manufacturing site for both clinical and commercial material. Ms. Bowen is a Subject Matter Expert in design, validation and operation of Sterile Product manufacturing and related equipment, cleaning and analytical methods. Furthermore, she has demonstrated success in capital project delivery: new powder filling facility and new biotech upstream processing facility. 
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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