QbD-Quality by Design-Resource Guides and Webseminar

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Purchase the “QbD-Quality by Design-Resource Guides and Webseminar” handbook and CD-ROM for $475.00 online from IndustryMatter.com.

This reference guide for pharmaceutical production and manufacturing provides an incredible amount of information about the changes advanced in the process of drug discovery, drug development and drug manufacturing. Learn how quality can be designed into pharmaceutical products and drugs through a comprehensive knowledge of the pharmaceutical, how the drug was developed and how it is manufacturing.

Pharmaceutical company executives will learn how to take advantage of knowledge acquired through the process lifecycle and will be able to quickly adjust to correct pharmaceutical manufacturing deficiencies.

QbD (Quality by Design)

Quality by Design (QbD) is now a buzzword but for decades it has been presented as a way to improve manufacturing process outcomes.

QbD (Quality by Design): A systematic approach to product and process design and Understanding the Challenges behind QbD – A review of leading practices and development, has been compiled from Pharmaceutical Technology, BioPharm International and The Institute for Validation Technology to provide valuable insight into the topic and assist you in making the business case for QbD based on the criteria decision makers need to evaluate new initiatives and related technology.

QbD (Quality by Design) Volume I includes:

The Outlook for Quality by Design
The New Era of Process Validation
How to Make the Business Case for Quality by Design
Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes, Part 1
Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes, Part 2
Quality by Design in the CMO Environment
And much more!

QbD (Quality by Design) Volume II includes:

QbD: Convincing the Skeptics
Analytical Tools for Process and Product Characterization
Quality by Design and Compliance Readiness
Critical Challenges to Implementing QbD
Global Regulatory Submissions for QbD
And much more!

Understanding the Challenges Behind QbD - A Review of Leading Practices (webseminar)

You will learn:

· How to think about existing QbD programs

· Key best practices from a CRADA Research Study

· How to leverage the benefits of QbD

Who will benefit:

You will benefit from this material if you are from the biotech or pharmaceutical industry with responsibilities or involvement in the following areas:

Regulatory Affairs

QA/QC/IPC

Development

Manufacturing Operations

Engineering

Validation
Pharmaceutical and Process Development

Chemical, Biochemical and Synthesis Development

Analytical Development

Manufacturing

Quality Management

Validation/Qualification Managers