We can help you build a culture of compliance

 

Building the right culture can be just as important as solving individual problems. We can mentor and coach your c-suite and executives to help build a culture of support for supply chain excellence and break down silos within companies or around the world. What separates us is the storytelling. We have a myriad of examples, based on our experiences, that make for memorable content that people can relate to their own situations.

 

Quality oversight and audit preparedness  - on or off site -

• Audits

  • Vendor

  • Internal

  • GMP, GCP, GLP, GDP, etc.

  • QP

 

• Preparation of Quality Manual, Policy, Mission, etc.

 

• SOPs

  • Developments/improvements

  • GAP analysis

  • SME inputs for review and approval, & accreditation

  • Evaluation of current SOPs

  • Quality assurance review and approval....meaning we will be your Quality sign-off for SOPs etc if needed.

 

• Monitor Manufacturing, packaging, labeling, review and approve label text & proof approvals

 

• Batch record review/generation

 

• Investigational product release

 

• Risk assessment – supply chain

  • FMEA Failure Mode and Effects Analysis

 

• Complaint management system/support

 

• Root cause analysis

 

• CAPA System Corrective Action/Preventative Action

 

• Risk management program

 

• PQMS - Pharmaceutical Quality Management System

 

• Quality/Technical agreements

 

• Validation – equipment validation, facility and process

 

• Temperature control, mapping, and monitoring

 

• Regulatory – Reduce Regulatory Risk

  • TMF/DMF assessment & gap analysis (Trial Master File / Drug Master File)

  • PAI  (Pre-approval inspection) presence, readiness and response support current and post

  • Inspection readiness, training and coaching