Quality

Compliance

Callaway Solutions  specializes in solving complex challenges. Our experienced compliance consulting professionals will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

From early concept development through each clinical phase, product launch, and commercialization, our Quality and Compliance Consultants partner with clients around the world to help ensure regulatory expectations are met, such as compliance where   business goals are achieved, and patient health and safety is assured and improved. We do this with an unwavering focus on delivering the highest quality services through our diverse team of qualified subject matter experts (SMEs). Having working experiences from large international corporations to small research companies as well as authorities such as FDA, EMA,  and national competent authorities, our experts drive operational excellence and provide a sincere commitment to providing high-quality services. Our ability to be nimble coupled with a passion for excellence ensures our consulting services exceed clients’ expectations.

Callaway Solutions performs quality and compliance consulting activities in all GxP areas. Our consultants have extensive management and operational experience in at least one GxP area (GMP, GDP, GVP, GCP, GLP, GCLP, and CSV) and often in multiple areas of expertise. DMAIC model (define, measure, analyze, improve, control.

SAP,QMS,TRACKWISE,ETS,MES,VAULT,VEEVA, DELTA V

Quality Assurance (QA)

• QA Methodologies & Systems
• Corrective & Preventive Actions
• Risk Mitigation
• Regulatory Compliance
• Audit, Inspection & Root Cause Analysis
• Quality Reporting & Change Control
• Continuous Process Improvement
• On the floor QA Operations & Investigations
• Investigation Reviewer & Approver
• FDA 21 CFR Part 11

Environment Control (EC)

• Aseptic Processing Engineering
• Aseptic Process Engineering Coach
• Support Aseptic Manufacturing Areas 
• Planning, Execution, Tracking
• Completion of Key Aseptic Projects - such as but not limited to:
  • PQS Review/Implementation
  • Shutdown/Restart Process
  • Aseptic Review Board
  • Media Fill Planning & Oversight
  • Investigations
  • Smoke Studies
  • Aseptic Technic Evaluation
  • Contamination Control
  • Change Management