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The QbD Toolbox: Resources That Help New QbD Programs

  September 19, 2017  
CfPA-The Center for Professional Advancement, Online Live
October 19, 2017 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend?
You are charged with exploring or implementing a QbD effort within your organization. The documents that explain the Quality-by-Design concept devote twenty pages to the aims, goals and expectations of QbD in the Pharma manufacturing industry. Your team is formed, at least on paper. Now what do you do? The QbD core elements; Knowledge Base, Risk Management and Experimentation are in the documents but you need to understand them and make them work within your company and product needs. This course provides a guide to extracting the resources that you will need from your internal operations (knowledge base;) establish and apply metrics that take risk management out of the conceptual framework; and will suggest tools that simplify your experiments. It is intended for:

  • QbD project managers
  • QbD team members
  • New product unit managers
  • Analytical method developers
  • Technology transfer specialists
  • Personnel concerned with process analysis and control
  • Unit operations staff 
  • Quality staff and managers, QC staff and managers

Course Description
This 90-minute accredited training course presents methods that assist both QbD team members and process operations personnel in maximizing the value of product history. Risk Priority Number is an extremely useful metric for risk management only when its defining scales are appropriate. This course aids participants in establishing scales that make sense. In its experiment section, the course addresses simplified factorial analysis to reduce the sheer number of experiments, multivariate data analysis and software that will perform these experiments efficiently. At its conclusion, participants will have a toolbox of options for managing the details of a QbD program.

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

This course will be available On Demand: October 20, 2017
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: jmorbit@cfpa.com
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