Acceptance Activities in FDA QSR 2018

Topics

• How purchasing and acceptance activities are linked and combine to facilitate effective supplier management
• Some of the specialized terms from QSR
• The required activities to release a finished device for distribution
• Guidance on when in-process acceptance activities are required
• The role of sampling plans in acceptance activities
• The acceptance activity records to keep and how they relate to Device History Record (DHR)
• The competence requirements for people who perform acceptance activities

Who should Attend

• Operations Managers
• Design Engineers, Especially those Involved in Design Transfer
• Production Supervisors
• Production Managers
• Purchasing Agents
• Purchasing Managers
• Quality Engineers
• Quality Managers
• Manufacturing Engineers