ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)
Preparation for the ASQ Certified Pharmaceutical GMP Professional exam. The programme covers regulatory governance, pharmaceutical quality systems, laboratories, facilities and utilities, materials and supply chain, sterile and non-sterile manufacturing, packaging and labelling, and technology transfer.
At a glance
- 15 days · Part-time, Fridays
Who it's for
- QA/QC professionals in pharmaceutical, biologics & veterinary manufacturing
- Production, validation & regulatory affairs staff
- Candidates for the ASQ CPGP exam (5 years' experience required)
Learning objectives
- Understand global GMP regulatory frameworks and inspections
- Apply pharmaceutical quality systems (ICH Q9 risk, ICH Q10 PQS, CAPA, change control)
- Evaluate laboratory, infrastructure and validation requirements
- Control materials, sterile/non-sterile manufacturing, filling, packaging and labelling
- Apply QbD and technology transfer principles
- Prepare for the CPGP exam
Detailed content
- Global framework: FDA, EMA, PIC/S, WHO, ICH, Health Canada
- Regulations & guidances
- Mutual recognition agreements
- Inspections & enforcement actions
- Regulatory reporting (post-approval changes, field alerts, recalls)
- SMF, VMP, DMF
- Pharmaceutical QMS (ICH Q10)
- Quality unit & Qualified Person
- Quality risk management (ICH Q9(R1))
- Training & qualification
- Change control
- Investigations & CAPA
- Audits & self-inspections
- Documents, records & data integrity
- Complaints & adverse events
- APR/PQR
- Supplier & contractor quality
- USP / Ph. Eur. / JP compendia
- OOS/OOT investigations
- Instrument qualification & calibration
- Specifications
- Lab records & data integrity, COAs
- Sample & reagent handling
- Stability programs
- Retained samples
- Facility design & change control
- Water, compressed air & gas systems
- Equipment design, cleaning & cleaning validation
- DQ/IQ/OQ/PQ, FAT/SAT
- Maintenance & metrology
- Cleaning, sanitisation & sterilisation
- Computerised systems (21 CFR Part 11 / EU Annex
- 11)
- Business continuity
- Receipt & inventory control
- Sampling
- Storage, FIFO/FEFO, mix-up prevention
- Shipping, GDP, cold chain, serialisation
- Traceability & sourcing
- Returned goods & destruction
- Batch records
- Production operations
- In-process controls, CPPs, Cp/Cpk
- Dispensing & weighing
- Critical unit processes & media fills
- Environmental monitoring (EU GMP Annex 1, 2022)
- Contamination control strategy
- Reprocessing & rework
- Filling controls
- Environmental monitoring
- In-process & finished-goods inspection
- Packaging controls & line clearance
- Labelling controls & reconciliation
- Packaging records
- Transfer
- Quality by Design: CQAs, CPPs, design space, PAT
- Phase-appropriate GMP & clinical trial materials
- Combination products
- Scale-up & technology transfer
- Practice questions & mock exam
Practice, tools and assessment
Hands-on practice
- Aspects-and-impacts register for a real site
- Compliance-obligations review exercise
- Build a HACCP plan for one product: flow diagram, hazards, CCPs, limits
- PRP/GMP inspection walk with nonconformity reporting
Tools and templates you keep
- Aspects/impacts significance matrix
- Legal register template
- HACCP plan worksheets (hazard analysis, CCP decision tree)
- PRP/GMP inspection checklist
How learning is assessed
- Diagnostic test on day one to focus study time
- Chapter quizzes and a full timed mock exam in the official format
- Personal study plan until your exam date
Built on these standards and bodies of knowledge
- ISO 14001:2015
- Egyptian Environmental Law 4/1994 and executive regulations
- Codex Alimentarius CXC 1-1969 (General Principles of Food Hygiene, 2022)
Certificate
Excellence Center Certificate of Completion (exam preparation). CREDENTIAL EXAM The ASQ CPGP credential is awarded by ASQ (American Society for Quality). Candidates confirm eligibility and register for the exam directly with ASQ.
The exam is set and the credential awarded by ASQ. The Excellence Center provides preparation; it does not award ASQ credentials.
This program prepares for a certificate from a body on the Saudi HRDF (Hadaf) Professional Certificates list. Saudi citizens may be able to claim a fixed reimbursement of the certificate cost from HRDF: up to two certificates per person, after passing the exam, if the certificate is on HRDF's current list and the employer did not pay for it. HRDF approves the certificate, not the training provider. Check the HRDF website before enrolling. All HRDF-listed programs · Enrol in Saudi Arabia with our partner Elm E · HRDF
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 ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)?
The program runs 15 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
- 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 Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 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.