GMP Auditor Training for Quality Systems
Conduct GMP audits that add value. Participants learn audit models, tools and techniques, run audits from planning to close-out, and practise auditing CAPA, OOS and QRM systems, API and finished- product manufacturers, and suppliers and contractors.
At a glance
- 2 days · Core
- 3 days · With all workshops
Who it's for
- QA auditors and trainees; production & engineering managers receiving audits; supervisors leading self-inspections; supplier auditors
Learning objectives
- Plan, conduct and report internal (self- inspection), supplier and contractor GMP audits
- Classify observations and follow up CAPA effectively
- Audit CAPA, OOS investigations and quality risk management
- Apply audit checklists for API and finished- product manufacturers
Detailed content
- Purpose of GMP audits and audit models
- Audit types: self-inspection, supplier, regulatory
- Auditor characteristics and ethics
- Audit planning and scheduling
- Checklists and sampling
- Interviewing and observation techniques
- Conducting the audit and managing the team
- Exit meeting
- Reporting, grading and close-out
- Structured investigations
- CAPA effectiveness
- OOS and OOT investigations
- Quality risk management (ICH Q9)
- ICH Q7 for APIs
- Oral solid and liquid forms
- Packaging, labelling and distribution
- QC laboratories and computerised systems (Annex 11)
- Technical requirements and critical controls
- Quality technical agreements
- Improving the audit and self-inspection programme
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Auditing basics
- Tools and techniques
- The audit process
- Auditing CAPA, OOS and QRM
- Auditing API and finished-product manufacturers
- Supplier and contractor approval
- Mock exam, review of weak areas and exam strategy
Practice, tools and assessment
Hands-on practice
- Solve a real problem with 8D or A3 from containment to verification
- Fishbone and 5-Why workshop with evidence checks
- Audit simulation: plan, interview, sample evidence and write findings
- Gap analysis of your own documents against the clauses
Tools and templates you keep
- 8D report and A3 templates
- Root-cause verification checklist
- Clause-by-clause gap-analysis checklist
- Audit plan, checklist and report templates
How learning is assessed
- Continuous assessment during audit role plays
- Written examination on the standard and audit practice
Built on these standards and bodies of knowledge
- Ford 8D / VDA problem-solving guidance
- ASQ Quality Improvement tools
- ISO 9001:2015 + Amd 1:2024
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
Frequently asked questions
How long is GMP Auditor Training for Quality Systems?
The program runs 2 days; other formats: 3 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.