How to inspection

cGMP Compliance Inspection

Master Inspection Readiness and Audit Execution with Confidence

This course provides a practical understanding of cGMP auditing from both perspectives — preparing for inspections and conducting inspections. It addresses the regulatory expectations of EU and US agencies and equips participants with the skills to manage internal and external audits effectively. The program teaches how to prepare documentation, handle inspectors, respond to findings, and maintain continual inspection readiness across the organization.

Target Group

This course is ideal for individuals involved in conducting, preparing, and evaluating audits and inspections, including:

Quality Teams

Production Teams

Regulatory Personnel

Validation Teams

Engineering & Technical Teams

Managers and Supervisors involved in compliance and inspection preparedness It is also relevant to professionals from regulatory authorities.

Course Outline

Overview of GMP inspections

The challenges of GMP audits

Regulatory requirements

Purposes and reasons for GMP audits

Audit types

Typical compliance issues

Quality System

Laboratory control

Production

Material Management

Facility & Equipment

Packaging & Labelling

Preparing and performing a GMP audit

How to perform and follow-up an audit

Audit program and planning / performing the audit

Audit reports and rating systems

Responses to the audit report

Action plan and tracking of major observations

Re-audit

The One-Day Audit — How to get a quick assessment of a company’s state of compliance

Inspection methodology and checklists

Interviewing inspectors and team interactions

Documentation sampling

How to make a risk-based audit schedule

Assessing risk between different operations

Identifying priorities for the audit

Point system to assign audit priorities

Developing a risk-based audit plan

Preparing for a GMP inspection

Preparing for national / international inspections

Internal audit expectations

Audit hierarchy

EU and FDA cGMP differences

Quality system audit details

Audit strategy and cycle

Roles and responsibilities

What do authorities expect?

FDA system-based inspections overview

Inspection focus areas

Experiences from an inspector’s point of view

Preparing for a regulatory inspection

Pre-inspection team gap analysis

Action plan and responsibilities

Training of staff on do’s / don’ts / etiquette

Conduct during inspection

Handling the opening day

Troubleshooting and corrective actions after findings

Duration

Two days

Key Takeaways

Strong understanding of cGMP audit and inspection requirements

Ability to prepare documentation, teams, and systems for FDA/EU audits

Confidence in managing audit interviews and cross-functional audit coordination

Practical approach to responding to findings and building sustainable inspection readiness

Ability to develop a risk-based audit schedule and long-term audit strategy

Speak to a Training Specialist

Contact

Building #10, Ground Floor, Business Park, Amman, Jordan
+962 (79) 1533337
m.abuzour@agonme.com

Brochures

Download Brochure

Services

Management Representative

Training Programs

How to inspection