Your destination for
Clinical Quality System Consulting
and Independent Auditing support
since 2017.
Credentialed Auditing (RQAP-GCP), Monitoring (CCRA), Training (TIACR) and Medical Device (ACRP-MDP) professional with 25 years’ experience with a full service clinical CRO (NCRA) and 5+ years as an independent consultant. Experienced with drug, device and nutraceutical development, Ms. Guest currently provides routine and specialty GCP independent third-party auditing services, mock FDA inspections, clinical quality management system (QMS) consulting and customized training on regulated research and Good Clinical Practices.
Glenda Guest, RQAP-GCP, CCRA, TIACR, ACRP-MDP, FACRP
| Auditing – routine or “for cause” | Mock FDA and Inspection Readiness | QMS Development and Consulting | Training |
|---|---|---|---|
| Vendor Qualification and Re-qualification | Clinical Investigator | Research Sites | FDA Regulations Drugs |
| Clinical Investigator, including Phase I | Sponsor | Clinical Departments | FDA Regulations Devices |
| Sponsor | IRB | Sponsor | GCP Basics to Advanced |
| IRB | Vendor | IRB | Custom GCP and FDA Regulatory for your teams |