FAQs

Auditing and Quality Services

Each audit is specifically catered to your concerns, products and services. As such the price for auditing services will be negotiated with each client.

As industry experts with 20 years of experience,  we work until our client(s) are satisfied. With GxP Solutions, expect more.

NOTE: Only North America (on-site) Audits or Remote Audits will be performed.

Each Audit Includes the Following Activities and Targeted Hours for Completion:

1 – Auditor Training (1 hr) – (e.g., On Client Procedures, if required)

2 – A Pre-Audit Meeting (1 hr) – (e.g., To Determine the Audit Scope)

3 – Project Management (2 hr) – (e.g., Audit and Travel Scheduling, In-House Peer Review of Audit Reports, etc.)

4 – Audit Preparation (18 hrs) – (e.g., Develop the Audit Plan, Audit Notification Letter, Audit Agenda, Pre-Audit Document Request, etc.)

5 – Audit Conduct (8 hrs – For Each Audit Day)

6 – Client Debrief (1 hr) – Short Summary or Meeting Covering the Audit Findings.

6 – Audit Report Writing (16 hrs – 1-Day Audit / 20 hrs – 2-Day Audit)

7 – Post Audit Activities (2 hrs) – (e.g., Audit Observation Report, Audit Certificate, etc.)

Note:

1 – All Critical Findings Will Be Escalated to The Client Within 24 Hours.

2 – Audit Related Travel Time Will Be Paid at 50% of The Hourly Rate.

Training Services

Each course is specifically catered to your concerns, products and services. As such the price for training services will be negotiated with each client.

GxP Training Courses – In GCP, GCLP, GLP, GVP, GMP, GDP, and CSV disciplines:

Option 1 – General Training Courses

Option 2 – Auditing Courses

Note: All Courses are live and instructor led. Courses will be offered at the end of each Quarter. Please contact info@gxpsolutions-pharma.com to schedule the course desired.