How to Integrate Quality by Efficient Design (QbED) in Product Development

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Bhavishya Mittal (Vice-President, Product Development and Manufacturing, BioDuro-Sundia)

How to Integrate Quality by Efficient Design

Name: How to Integrate Quality by Efficient Design
Price: 268.95 AUD
Availability: OutOfStock
ISBN: 9780128168134

QbED in Product Development

Bhavishya Mittal (Vice-President, Product Development and Manufacturing, BioDuro-Sundia)

$268.95

Paperback

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English

Academic Press Inc
27 August 2019

Production & quality control management; Pharmaceutical industries; Pharmacology; Pharmacy & dispensing

Series: Expertise in Pharmaceutical Process Technology

Quality by Efficient Design (QbED): How to do Pharmaceutical Outsourcing Efficiently in the Age of QbD

By: Bhavishya Mittal (Vice-President Product Development and Manufacturing BioDuro-Sundia)
Imprint: Academic Press Inc
Country of Publication: United States
Dimensions: Height: 229mm, Width: 152mm,
Weight: 430g
ISBN: 9780128168134
ISBN 10: 0128168137
Series: Expertise in Pharmaceutical Process Technology
Pages: 274
Publication Date: 27 August 2019
Audience: College/higher education , Primary
Format: Paperback
Publisher's Status: Active

1. Health Care: A Societal Benchmark2. Pharmaceuticals: A Highly Innovative Business3. Pharmaceutical Productivity: Challenges and Opportunities4. QbD: A Welcome Evolution5. QbED: An Emerging Concept6. Adaptive Product Designs: A Wave of the Future7. Patient-Centric Drug Product Designs: A Business Necessity8. Manufacturing Excellence: Only Road to Continual Improvement9. Case Studies and Supplemental Resources

Bhavishya Mittal is the Vice-President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro, Bhavi worked at Kronos Bio, AbbVie, US FDA, Takeda, and Astellas Pharmaceuticals. Bhavi is also an adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA). He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India). Bhavi has 21+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings. He is the Chair for the Manufacturing Sciences and Engineering (MSE) community of AAPS. He is the author of 3 published books (with 25 combined chapters), 4 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to pharmaceutical manufacturing sciences.