|
|
|
By Amanda McFarland and Ryan Murray, ValSource, Inc. | This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like. |
|
|
|
By Peter Alexander and Phillip Ramsey | The principles of an effective technology transfer can apply at every stage of the drug development life cycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down. |
|
|
|
A conversation with Linda Pissott Reig, REMS Industry Consortium | The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios. |
|
|
|
By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC | The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance. |
|
|
|
|
|
|
|
|
|
|
|
LIFE SCIENCE LEADER MAGAZINE |
|
|
|
Have you heard of Life Science Leader? Check it out today for access to candid interviews with top-tier executives on how they do business. |
|
|