Laboratory Inspection Readiness - Implementing GMPS for the Pharmaceutical Laboratory 2017

Topics

• Personnel organization and records
• Types of inspections
• Key SOPs every lab should have, and related training and maintenance
• Instrument inventory, qualification and change control
• Documentation of analytical procedures, including validation, verification and change control
• Log of out of specification results
• Trending of analytical data, laboratory incidents and OOS reports
• Documentation of analytical data and reports
• Attendee questions and answers
• Brief introduction to expectations for computer systems

Who should Attend

• Laboratory Managers
• Chemists
• Quality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspection
• Regulatory Affairs
• Documentation
• IT/IS