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This book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of adoption, implementation and interpretation of Quality by Design is currently the key driver to help industry bring products to market faster and at the same time provide maximum assurance of product quality. Though pharmaceutical companies need to abide the law and therefore comply with the applicable laws, rules and regulations, their goal must be to be profitable. A business case must therefore not only outline how compliance can be achieved, maintained and improved, but also how this will result in a positive financial impact. Global subject matter experts offer invaluable information that will guide companies who wish to:
- Proactively address regulatory trends
- Reduce or eliminate the number of reworked batches
- Achieve better manufacturability and process robustness
- Drastically reduce recalls
- Achieve leadership in the industry
Book written in February, 2011
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Format: PDF (1 file 9.51 MB)
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Table of Contents:
Click here to download >>>Detailed Table of Contents
Chapter 1: Introduction by Siegfried SchmittChapter 2: The Regulatory Framework by Siegfried Schmitt. Click here
to download >>>Chapter 2
Chapter 3: The Roadmap to QbD by Siegfried SchmittChapter 4: Simplified Process Development and Commercialization by Girish
MalhotraChapter 5: Change Management Associated with QbD Implementation by
Michael Schousboe and Irwin HirshChapter 6: QbD and Process Validation — Complementary Lifecycle Approaches
by Paul L. PlutaChapter 7: The Analytical Challenge in QbD — From Data to information and to
Knowledge — From (Bioprocess) Development to Manufacturing by Christoph
HerwigChapter 8: Applying QbD Design to Pharmaceutical Microbiology by Jeanne
MoldenhauerChapter 9: The QbD Challenge for Analytical Laboratories by Terry
HopperChapter 10: Compliance by Design (CbD) and Compliance Master Plan (CMP) —
Lifecycle Approach to Quality Systems and Compliance by Paul L. Pluta,
Richard Poska and Timothy J. FieldsChapter 11: The Regulatory Perspective for Small Molecules Related to
Variations by Salma MichorChapter 12: Role of the University in Teaching QbD by Siegfried
Schmitt
About the Editor
Siegfried Schmitt, Principal Consultant, joined PAREXEL
Consulting in 2007. He provides consulting services to the medical device and
pharmaceutical industry on all aspects of regulatory compliance, particularly
the design and implementation of Quality Management Systems and Competitive
Compliance. Dr Schmitt's areas of expertise include all aspects of quality and
compliance for the product lifecycle, from R&D, to clinical trials, to
commercialisation and post-marketing studies. He has previously held positions
in industry as Senior Production Chemist with Roche and global Quality Director
with GE Healthcare, and as Validation Manager with Raytheon and Senior Lead
Consultant with ABB. Dr Schmitt is an active member of various industry
associations, including DIA, PDA, RAPS and ISPE, conference presenter and
organiser of international events. He is also an accomplished author and editor,
having won the coveted distinguished PDA author / editor award’ for 2008. Dr
Schmitt is a Chemist by background and holds Chartered Chemist and Chartered
Scientist status. He is fluent in English and German.