Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™

About the Author

Quality Fundamentals Area Lead

Roche

Nuha Al-Hafez has has worked in the biopharmaceutical industry for more than 25 years in operations and quality in innovation, generic, and CMO sectors. Nuha...

Theresa Allyn

Senior Director, Global QA

F. Hoffmann-La Roche

Theresa Allyn is an alumnus of the molecular cell biology graduate program at the University of California, Berkeley. With over 20 years in the biopharmaceutical...

Yvonne Duckworth, PE

Fellow - Digital Technology, Associate

CRB

Yvonne Duckworth is a world-renowned speaker and subject matter expert on Pharma 4.0. She serves as a chairperson on the ISPE Pharma 4.0™ Leadership Team...

Robert W. Landertinger Forero

Head of QA in Drug Product

Sanofi-Aventis Pharma Deutschland GmbH

Robert W. Landertinger Forero has a degree in biotech engineering. Robert leads a team of quality experts for visual inspection of drug products, insulins, and...

Lothar Hartmann

Managing Director

PhACT

Lothar Hartmann, PhD, obtained his diploma and PhD in technical chemistry from the Technical University of Berlin. He joined Hoffmann-La Roche in 1988 and served...

Line Lundsberg-Nielsen, PhD

Managing Consultant, Compliance Consulting

NNE

Line is a physicist and holds a Ph.D. in PAT. Her background is pharmaceutical manufacturing and development, and she is passionate about the Control Strategy...

Daniel J. Roberts

Senior Specialist Pharmaceutical and Biotechnology Practice

Hogan Lovells

Daniel J. Roberts has over 19 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was a US FDA investigator for eight years, including two...

Joost Van Den Broeck

MSAT Cluster Head for Oncology Products

Sanofi

Joost Van Den Broeck holds a master’s degree in biomedical sciences from Hasselt University in Belgium. He started working at Genzyme in 2010 in quality...

Thomas Zimmer, PhD

VP European Operations

ISPE

Thomas Zimmer, PhD, is ISPE Vice President, European Operations. He previously was Senior Vice President of the Corporate Division, Safety, Quality & Environmental Protection at...

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