Batch Production Record and Device History Record Review and Quality Assessment 2014

Topics

• Production and In-Process Controls
• Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors. Training is NOT the primary means of generating and error free operation
• Responsibilities for Production Activities
• Inspection, Packaging and Identification Labeling of Finished Products and Intermediates
• Incident / Deviation Tracking along with Customer Complaints and CAPA changes
• Data selection and entry into the statistical tracking from the BPR and DHR
• Annual Reports

Who should Attend

• Documentation Personnel
• Quality