'Little things' blossomed into big QA trouble at J&J/McNeil

"When they leave, they take the routine with them," said an anonymous former J&J/McNeil worker of QA staff reductions following the company's acquisition of Pfizer Consumer Healthcare in 2006. "It can be a couple of little things that are let go and turn into problems, like machine parts wearing out." An investigation into metal particle contamination of Infants' Tylenol from the company's Fort Washington, PA, plant cited metal-on-metal wear of pistons in bottling-line equipment as the probable source. The plant, voluntarily closed in April 2010 and now under consent decree with the FDA, is undergoing a $100 million remediation. Story


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.