Process based services

• Risk Management process and file review
• Sterilization and packaging validation reports review
• Special processes validation reports review

Management

• Liaise and coordinate with NB and regulatory agencies through acting as company management representative
• Assist in preparing and driving company quality objectives and goals utilizing process approach module
• Review and fine-tune company quality policies to facilitate establishment of quality objectives
• Support management review efforts

Supplier management

• Perform initial qualification efforts
• Audit and continually review supplier performance

Correction and preventive action management

• Respond to nonconformances / deficiencies with assistance in identification of root cause analysis
• Issue and effective action plans for major nonconformances
• Assistance in CAPA review meeting
• CAPA verification and effectiveness check

Design and development efforts

• General design plan assessment
• Design risk based approach (design failure mode and effect analysis)
• Independent D&D review
• Assess design changes
• Review and analyze design transfer activities
• Change notice package review prior to notified body and/or regulatory agency submission