Reducing Drug and Device Batch Release Times: Improving your BPR/DHR Review and Assessment 2016

Topics

• Production and in-process controls
• Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors
• 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

• Compliance personnel
• QA/QC personnel
• Process validation and Lean Six Sigma experts
• Manufacturing and operations executives
• SOP development and training executives
• Regulatory affairs professionals