Tim Flanigan
Lockwood Green
Keeping Up To Date With Current
Good Manufacturing Practice
Abstract
The
pharmaceutical and biotech industries are highly regulated by rules that are
constantly changing. It is incumbent upon engineers who are working in this area
to remain up to date with Current Good Manufacturing Practices (cGMP), and to
have an good understanding of the role that
engineering design plays in the successful validation of a manufacturing
facility. Implementation of a
well-defined Good Engineering Practices (GEP) program at the initiation of a
project will greatly simplify validation procedures by addressing engineering
related issues that are important to the validation effort as they emerge. A good GEP program includes areas such as GMP
reviews, facility layout, material and personnel flow, equipment specifications
and system boundaries. This talk will
focus on recent changes to the cGMP regulations that affect engineering design
and validation, and will discuss the extent to which changes can affect the
manufacturing process during the design phase of the project.
Bio
Tim Flanigan
is Director of Validation and Regulatory Affairs for Lockwood Greene in