1. 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks. (March 2016) Authors: Hayes, Roger; LeLacheur, Richard; Dumont, Isabelle; Couerbe, Philippe; Safavi, Afshin; Islam, Rafiq; Pattison, Colin; Cape, Stephanie; Rocci, Mario; Briscoe, Chad; Cojocaru, Laura; Groeber, Elizabeth; Silvestro, Luigi; Bravo, Jennifer; Shoup, Ron; Verville, Manon; Zimmer, Jennifer; Caturla, Maria... Journal: Bioanalysis Issue: Volume 8:Number 6(2016) Page Start: 487 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud. (April 2017) Authors: Cape, Stephanie; Islam, Rafiq; Nehls, Corey; Allinson, John; Safavi, Afshin; Bennett, Patrick; Hulse, James; Beaver, Chris; Khan, Masood; Karnik, Shane; Caturla, Maria Cruz; Lowes, Steve; Iordachescu, Adriana; Silvestro, Luigi; Tayyem, Rabab; Shoup, Ron; Mowery, Stephanie; Keyhani, Anahita; Wakef... Journal: Bioanalysis Issue: Volume 9:Number 7(2017) Page Start: 505 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗