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GMP Refresher Course & Certification
Intermediate
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4.6
★★★★★
95% Recommended
3 hours
166 active users
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About
The GMP Refresher Course & Certification is designed to reinforce and update knowledge of Good Manufacturing Practice (GMP) principles for professionals working in pharmaceutical and life sciences industries. The course focuses on maintaining compliance, improving quality awareness, and ensuring consistent application of GMP standards in day-to-day operations.
This course covers key GMP principles, regulatory updates, documentation practices, hygiene and contamination control, deviation and change control systems, audit readiness, and quality management fundamentals. It also emphasizes current industry expectations, inspection preparedness, and best practices for maintaining a strong quality culture. Upon successful completion, learners receive a certification demonstrating refreshed competency in GMP compliance.
Who Should Enrol?
- Pharmaceutical Manufacturing Professionals
- Quality Assurance and Quality Control Personnel
- Production and Operations Teams
- Regulatory Affairs Professionals
- Warehouse, Packaging, and Supply Chain Staff
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, and Engineering Graduates
What you will learn
Refresh understanding of core Good Manufacturing Practice (GMP) principles, including regulatory expectations and day-to-day compliance requirements.
Strengthen knowledge of data integrity (ALCOA+), good documentation practices, and the importance of accurate, reliable records.
Learn key quality systems such as deviations, CAPA, root cause analysis, manufacturing controls, and laboratory compliance practices.
Develop awareness of risk management, quality culture, audit readiness, and common GMP failures through real-world case studies and inspection insights.
Course Syllabus
- Welcome to the GMP Refresher
- FDA inspection trends 2024-2026
- MHRA inspection trends
- EMA inspection trends
- How findings translate to consequences
- Common GMP failures
- ICH guidelines anchoring GMP
- FDA framework
- Key regulatory updates 2023-2026
- Pharmaceutical Quality System (PQS)
- The 10 principles of GMP
- Documentation principles
- Personnel responsibilities
- Premises and equipment
- Production and quality control
- What is data integrity?
- ALCOA+ in depth
- Data integrity violations
- Real inspection findings
- Preventive controls
- Documentation hierarchy
- Batch Manufacturing Records
- Logbooks
- SOPs in operational use
- Common documentation errors
- Electronic documentation
- Deviations
- Root cause analysis
- CAPA discipline
- Trending and pattern analysis
- Inspection findings on deviations and CAPA
- Process validation
- CPPs and CQAs
- Change control
- Equipment qualification
- Cleaning validation
- Continued Process Verification
- QC laboratory role
- Analytical method validation
- Out-of-Specification (OOS)
- Out-of-Trend
- Laboratory data integrity
- Common laboratory findings
- ICH Q9(R1) — Quality Risk Management
- Human error prevention
- Quality culture
- Senior management role
- Measuring quality culture
- Building durable quality capability
- Inspection types
- FDA inspection process
- Preparing for inspection
- During the inspection
- Common 483 observations
- Responding to findings
- Anatomy of GMP failure
- Warning letter case studies
- Product recall case studies
- Consent decrees
- Cross-cutting themes
- Lessons applied
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to EU GMP Annex 1, ICH Q9 (R1), FDA 21 CFR 210/211 and current MHRA / EMA / FDA inspection priorities, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by GMP-experienced QPs and QA leads to ensure that learners can apply current expectations on the floor and in the QC laboratory.
Our Certified Customers
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