GMP Compliance for Quality Control and Contract Laboratories 2018

Topics

• Most frequently found deviations during inspections
• FDA and international regulations and guidelines
• Compliance along the laboratory workflow
• Major differences between GMP and non GMP laboratories
• Developing a project plan for step-by-step implementation
• Developing a laboratory compliance master plan
• Writing GMP compliant laboratory SOPs
• Implementing key requirements
• Qualification and maintenance of equipment
• Correct sampling and sample handling
• Handling out-of-specification situations, preventive and corrective actions
• Validation of analytical methods
• Acquisition, maintenance and archiving of records
• Qualification of suppliers and reference material
• Recommendations for implementation
• Preparation for FDA inspections

Who should Attend

• GLP/GCP/GMP auditors
• Laboratory managers and supervisors
• QA/QC managers and personnel
• ISO 17025 auditors
• Regulatory affairs
• Analysts and other laboratory staff
• Consultants
• Training departments