The Transformation to Process-Centered OrganizationBySimon ChalkNovember 1st 2012Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
Streamlining Batch Record Review and ApprovalBySimon ChalkAugust 1st 2012A one-day sign off for batch records is considered a best practice in the industry.
Using a Systematic Approach to Select Critical Process ParametersByThomas A. LittleJuly 1st 2012Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.