YQCQAD

YalePharma Quality Control & Quality Assurance Division

(1) QA and QC functions during product design, production and revision, with the role in production being dealt. (2) Current quality issues including FDA activities, the QA/QC aspects of a number of specific issues including: handling of laboratory controls, validation (equipment, processes, computers, cleaning and test methods), label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs), FDA inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training. (3) QA/QC aspects of stability program operation and also to documentation. YQCQAD is led by Marlene M. McKert, M.D., PharmD.

 

	R&D Section (RDS)
	Purchasing Section (PS)
	QA Section (QAS)
	Engineering Section (ES)
	QC Section (QCS)
	Maintenance Section (MS)
	Regulatory Affairs Section (RAS)
	Corporate/Plant Section (CPS)
	Plant Operations Management Section (POMS)