Articles by Paul Smock

Paul Smock

Paul Smock is a director and quality product leader in Wyeth Biotech, Wyeth Pharmaceuticals

Articles

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
May 1, 2013
By: Simon Chalk , Scott Probst , Ken Green , Russell Moser , Frank Urbanski , Matthew Zicaro , Paul Smock , Larry Pranzo , Liz Dooley , Phil McDuff

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

Quality by Design for Biotechnology Products—Part 3
January 1, 2010
By: Taruna Arora , Roger Greene , Jennifer Mercer , Paul Tsang , Meg Casais , Stuart Feldman , Jutta Look , Tony Lubiniecki , Joseph Mezzatesta , Stefanie Pluschkell , Mark Rosolowsky , Anurag S. Rathore, PhD , Mark Schenerman , Tim Schofield , Samantha Sheridan , Paul Smock , Sally Anliker , Lois Atkins , Bernerd McGarvey , Bruce Meiklejohn , Jim Precup

Regulatory flexibility can make continuous improvement possible.

Quality by Design for Biotechnology Products—Part 2
December 1, 2009
By: Taruna Arora , Roger Greene , Jennifer Mercer , Paul Tsang , Meg Casais , Stuart Feldman , Jutta Look , Tony Lubiniecki , Joseph Mezzatesta , Stefanie Pluschkell , Mark Rosolowsky , Anurag S. Rathore, PhD , Mark Schenerman , Tim Schofield , Samantha Sheridan , Paul Smock , Sally Anliker , Bernerd McGarvey , Bruce Meiklejohn , Jim Precup

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

Quality by Design for Biotechnology Products—Part 1
November 1, 2009
By: Taruna Arora , Roger Greene , Jennifer Mercer , Paul Tsang , Meg Casais , Stuart Feldman , Jutta Look , Tony Lubiniecki , Joseph Mezzatesta , Stefanie Pluschkell , Mark Rosolowsky , Anurag S. Rathore, PhD , Mark Schenerman , Tim Schofield , Samantha Sheridan , Paul Smock , Sally Anliker , Lois Atkins , Bernerd McGarvey , Bruce Meiklejohn , Jim Precup , John Towns

First in a three-part series that discusses the complexities of QbD implementation in biotech product development.