Site Inspection Preparation & Readiness

Site Inspection Preparation & Readiness

Course Overview

This course provides pharmaceutical industry professionals with the essential knowledge and skills required to effectively prepare for and manage regulatory site inspections, as well as third party customers. It covers inspection types, readiness strategies, common findings, and best practices for ensuring compliance with current Good Manufacturing Practices (cGMP) in line PIC/s guidelines. The training course incorporates theory & practical content, application and discussions.

Target Audience

• Quality Assurance (QA) and Compliance Teams
• Regulatory Affairs Professionals
• Manufacturing and Production Personnel
• Laboratory and R&D Staff
• Site Leadership and Management
• Any personnel involved in regulatory inspections

Course Objectives

By the end of this course, participants will be able to:

1. Understand the regulatory landscape and the role of inspections in pharmaceutical compliance.
2. Develop a site inspection readiness plan, including pre-inspection preparation, documentation review, and team roles.

3. Overview of the use of risk assessment and gap analysis tools as part of pre-inspection preparation.

1. Recognise common compliance gaps and implement corrective and preventive actions (CAPA).
2. Demonstrate best practices for interacting with inspectors, managing requests, and handling difficult questions.
3. Learn how to conduct mock inspections and internal audits to ensure continuous readiness.
4. Understand post-inspection procedures, including responding to observations and implementing follow-up actions.

Course Outcomes

Upon successful completion of this course, participants will:

1. Understand regulatory expectations applicable to their site.
2. Be able to develop and implement a site readiness program for inspections.
3. Improve confidence and communication skills when engaging with regulatory inspectors.
4. Identify and mitigate compliance risks
5. Effectively manage inspection findings and responses to regulatory authorities and third-party clients.
6. Foster a culture of continuous compliance and quality improvement in the company.