Manufacturing, Process Engineering & Controls

Good Manufacturing Practices Product Lifecycle Methods

Callaway Solutions knows how to leverage regulatory agencies’ requirements to ensure each phase of your product manufacturing lifecycle is successful.

• Evaluating the reliability of the product analytical methods
• Determining the methods perform as intended and are reproducible between laboratory and manufacturing sites
• Partnering with your organization to confirm every aspect of production occurs in a cGMP environment with the necessary controls in place, and evidence of those controls published

CGMP,GDP,GLP,GCP

SYSTEMS: DELTA V,VEEVA,VAULT,CIP,SIP,SAP,TRACKWISE,QTS,QMS

• Continuous Improvement
• Risk Management & Mitigation
• Change Control Management
• Manufacturing Execution System
• Cell Culture Processes  & Gene Therapy Processes
• Aseptic Filling Operations & Sterilization
• Aseptic Gowning Training
• Deviation Investigations & Batch Record Review 
• Bioreactors & BSC operations
• Upstream Manufacturing operations