Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle



Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

Date: November 15, 2016
Time: 1:00pm-2:30pm, EST US
Duration: 90 Minutes – Online
Price: $299 – Includes Bonus Handouts!
Course Description:

The ICH documents Q8, Q9, and Q10 have been gaining attention recently with the new FDA quality metrics initiative and the announcement of the FDA’s pilot program for training inspectors to assess a quality culture . This means that expectations set in these guidances won’t be optional for much longer, and organizations must assess their own operations for “Quality by Design” (QbD) compliance.

This process is confusing for many companies because it’s a very different way of thinking and working. Although the three documents are written as standalone entities, in order to implement them, all three must be used together. And worse, there are other guidances (like FDA’s Process Validation Guidance) and requirements (like the cGMPs) that have to be factored into the process. Furthermore, if one part of the organization is ready and another isn’t, the process defined in Q8, Q9, and Q10 will run into difficulties.

Spending the time to incorporate the latest QbD expectations into your operations is critical. In this interactive, 90-minute webinar you will learn:

• The differences between the old GMP mindset and the new quality systems mindset – and how they both affect our daily operations
• What each guidance covers, including scope and applicability to the various parts of the operations
• All of the parts required for an effective quality system (per these guidances and regulations), and how the systems should interact
• How to assess your own site processes and systems against the guidances

Who Should Attend
This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale. This includes quality, validation, manufacturing, development and all management personnel from sponsors and contract manufacturers (CMO) alike.

Instructor Bio
Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments. Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.

Over her career, she has held positions in quality assurance, laboratory and training roles, which enables her to translate operational experience into training. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result. She is well versed in instructional systems design, problem solving and root cause analysis skills, and she uses these skills to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.

Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, and interactive training design. She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was asked to join the GMP TEA, Inc. Board of Directors in 2008. She was one of the founders of and was an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.

Ad Reference ID: 2285829ff11e13a8

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