GMP Tips

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FDA New Strategic Plan released

August 22nd, 2011 · No Comments · Uncategorized

FDA just released their new strategic plan – Advancing Regulatory Science at FDA. Stay current – be proactive. Read this important document. Go to:
Click on FDA Resources

This plan outlines FDA’s approach to Quality by Design. Here’s a short excerpt.

Quality by Design is understanding the manufacturing process and identifying the key steps for obtaining and assuring a pre-defined final product quality. As part of its Quality by Design effort, FDA is now working on three new areas to support increased manufacturing quality. The first is continuous processing where materials constantly flow in and out of equipment. The second is the use of Process Analytical Technology to monitor and control processes, as opposed to the current method of just testing products. The third is the development of new statistical approaches to detect changes in process or product quality.

We recently conducted a web seminar on Quality by Design. It is available at:

Serving 1935 clients since 1996

Upcoming Boot Camps
Click below for our 2011 schedule

GMPs for Dietary Supplements
Sept 21 – 22

GMP Boot Camp – Fundamentals of GMP and QSR
Oct 19 – 20

Outsourcing Boot Camp
Oct 27 – 28

Upcoming web seminars
Cost effective & Convenient – in your office or conference room

Effectively Implementing CAPA
Sept 9

Defining Risk and Risk Levels: Implementing ICH Q9 – Quality Risk Management
Sept 16

Introduction to GMP – Orientation for New Employees
Sept 23

GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
Sept 30

Please forward this to others in your organization who may benefit.



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