Pharmaceutical, Medical Devices & Food Safety
Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop
A combined workshop on Good Laboratory and Good Manufacturing Practices. The GLP part covers lab essentials, validation, data integrity, stability and failure investigations; the GMP part covers basics, validation, compliance systems and regulatory inspections.
At a glance
Catalog codeD06
Duration
- 5 days · ≈ 40 hours
LevelPractitioner
Program typeTechnical
LanguageEnglish / Arabic
DeliveryIn-house · Public · Online
Who it's for
- Staff in GMP/GLP environments – beginners to advanced – who must understand and apply cGMP principles
Learning objectives
- Run QC laboratories to GLP expectations incl. data integrity
- Apply GMP basics, validation and compliance practices
- Prepare for and manage regulatory inspections
Detailed content
- Lab design: building, utilities, equipment
- Sample management; auditing QC labs
- Quality metrics; good documentation practices (ALCOA+); training
- Analytical method validation (ICH Q2(R2)/Q14)
- Equipment qualification D/I/O/PQ; system suitability
- Calibration & maintenance; essential documentation
- Regulatory expectations for data collection, storage, verification
- Data quality and lab investigations
- Post-approval changes (2 h)
- Stability testing (ICH Q1) (2 h)
- Deviations, test failures, OOS/OOT investigations, CAPA (4 h)
- Organization & personnel; facilities & equipment
- Effective SOPs; process controls & master batch records
- Vendor & material control; release & distribution; complaints & recalls
- Qualification vs validation; cleaning validation
- Cleanroom design & validation (EU GMP Annex 1, 2022)
- Sterilization validation; water system validation; documentation
- Internal audits; gap analysis & remediation
- CAPA & change control; GMP training
- Regulatory inspections – what inspectors expect
- Self-inspection & external audits
- Common deficiencies; warning letters & current hot topics
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- GLP 1 – Laboratory Essentials (4 h)
- GLP 2 – Laboratory Validation (4 h)
- GLP 3 – Data Reliability & Integrity (4 h)
- GLP 4 – Changes, Stability & Failures (8 h)
- GMP 1 – GMP Basics (4 h)
- GMP 2 – Validation (6 h)
- GMP 3 – Compliance (4 h)
- GMP 4 – Inspections & Non-compliances (6 h)
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Calculate OEE and the six big losses from a real machine log
- Failure analysis of a recent breakdown (5-Why, fishbone, FMEA)
- Build a preventive / autonomous maintenance plan for one asset
- Build a HACCP plan for one product: flow diagram, hazards, CCPs, limits
Tools and templates you keep
- OEE calculator (Excel)
- PM schedule and CIL (clean–inspect–lubricate) sheet
- Breakdown analysis report template
- HACCP plan worksheets (hazard analysis, CCP decision tree)
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- JIPM TPM pillars
- SMRP Body of Knowledge
- ISO 55000 (asset management)
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
- Pharma, Medical Devices & Food Safety · Practitioner
FAQ
Frequently asked questions
How long is Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop?
The program runs 5 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.
More programs in this field
- HACCP and Food Safety Risk Analysis
- ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)15 days
- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- GMP in Pharmaceutical Laboratories2 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 days
- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
- Pharmaceutical Water Systems: Principles & Practice2 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.