Gxp Compliance & Training Partners (Gctp)

Areas covered: 1. GCP, GVP, GDP, GLP & GCLP System and Process Audits. 2. Support with Audit /Inspection CAPA Management3. Vendor Qualification, Supplier Selection & Vendor In-Process "oversight" Audits. 4. Evaluation Audits of EU GVP QMS Implemention. 5. Formal QA Executive Representation. 6. Risk Management Plans and Evaluation. 7. SOP Development & Review8. Essential Documents (Protocol, Study Reports, ICF, etc. ) compliance audits. 9. Design of GCP, GLP & PV System Audit Programs. 10. FDA 483 Response Support11. Mock Regulatory Authority Inspections. 12. ISO 9001: 2015 Audits. 13. Clinical & Pharmacovigilance Systems Gap Analysis. 14. Development & Gap Analysis of GxP QMS15. Compliance reviews of promotional materials against applicable requirements (e. g. , ABPI). 16. Quality Manual development and review. 17. Scientific quality & review of clinical projects processes as external consultant18. Development and delivery of therapeutic area training to Medical Affairs, Medical Liaison Managers (MLS), Medical Representatives and R& D staff. 19. Pre-, During & Post-approval Inspection Support. 20. Review of IB, IMPD, Clinical Protocols, Informed Consent Forms, Clinical Study Reports (CSRs), TMFs. 21. Training on: 21. 1 Internal GCP, GCLP, GLP, GDP & GVP /Vigilance systems, exams & certification. 21. 2 SOP development21. 3 GCP, GLP and GVP Auditing21. 4 Protocol- and Investigator-specific GCP at Investigator Meetings21. 5 Medical Writing & Publishing21. 6 Inspection Readiness21. 7 Risk-Based Monitoring Systems21. 8 Clinical Research & Development21. 9 Pharmacovigilance Inspections: Preparation, Conduct & Hosting21. 10 Pre-Inspection Clinical Investigational21. 11 Site refresher GCP21. 13 Creation of GxP QMS21. 14 Good Distribution Practices (GDP)21. 15 Writing of Essential Documents (e. g. Clinical Protocol, ICF, etc. )22. Compliance reviews of Clinical Trials protocols, Informed Consents, DSURs, CSRs PSURs, PBRER, Investigator Brochures (IB)
Social Link - Linkedin: http://www. linkedin.com/company /gctp-consulting
Employee Count: 1
Keywords: medical