© 2019 by GBS

Quality and Regulatory Compliance

“Quality is everyone's responsibility.”

                               

                           -W. Edwards Deming

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

 

 

 

IDS Support

Bring us in when…​

  • An IDS audit has ended with multiple findings​​​...

 

Media

Why and How To Interactively Facilitate Workshops...

 

Training and Education

Building the right culture can be just as important as solving individual problems. We have an energizing...