Course description
Pharmaceutical GMP Training
Whether you’re just starting in the industry or an experienced staff member, this highly interactive GMP pharmaceutical training course will teach you how to apply pharmaceutical GMP in your workplace and keep you up to date with industry requirements.
Covering important sections of the ever-changing EudraLex Volume 4, you will leave with a thorough understanding of the essentials of GMP. You will be able to identify up-to-the-minute information on new and existing pharmaceutical GMP initiatives and regulations.
The course provides an excellent opportunity to share your GMP questions with experienced industry experts and get practical advice first-hand.
Our virtual classroom option combines 12 hours of instructor-led classroom training split over three days and 9 hours of self-paced learning to provide an engaging learning experience. Our team will email full details following registration.
Suitability - Who should attend?
Attend this pharmaceutical GMP course if you work in management, QA, QC, production, engineering and supply chain, and you want to broaden your knowledge in pharmaceutical GMPs. This course is suitable for newcomers to the industry who wish to understand the essentials of pharmaceutical GMP.
The course will also benefit suppliers of materials and services to the pharmaceutical industry to understand GMP requirements.
Outcome / Qualification etc.
On completion of this course, learners will be able to:
- Explain the origin and reasons for GMP
- Interpret key European and U.S. GMP legislation
- Apply the practical interpretation of GMP expectations and best practices
- Identify EudraLex and PIC/S expectations
- Relate premises, processes, products, procedures, people and GMP
Training Course Content
Day 1
- Overview of EU law and requirements relating to medicines
- EudraLex Volume 4
- What does the patient want?
- ICH Q9 and Q10
- Pharmaceutical quality systems
- Management responsibilities
- Documentation and records
- Validation - the basics
- Calibration and maintenance
- Human error
Day 2
- Supplier assurance
- Control of starting materials
- GMP requirements for different dose forms/routes of administration
- Facility design
- Good Control Laboratory Practice
- Self-inspections
Day 3
- Utilities and water systems
- Change management
- Investigations - deviations and CAPA
- Complaints, quality defects and recalls
- Training
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 4.6
Perfect course materials and excellent instructor knowledge of the subject. Tutors are very experienced and friendly.
Good knowledge from instructors, well-structured course materials.
Expenses
Discounts
Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.
Course is good and useful for all streams of pharma industry.