Pharmaceutical GMP Training
About This Course
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 instructor-led training course provides an engaging learning experience. Our team will email full details following registration.
Key Learning Objectives
On completion of this course, learners will be able to:
- Explain the origin and reasons for GMP
- Apply the practical interpretation of GMP expectations and best practices
- Identify EudraLex and PIC/S expectations
Course Outline
- Overview of EU law and requirements relating to medicines
- EudraLex Volume 4
- Quality Risk Management - ICH Q9
- Pharmaceutical quality systems and ICH Q10
- Management responsibilities
- Documentation and records
- Validation - the basics
- Supplier assurance
- Facility design and GMP requirements for different dose forms/routes of administration
- Good Control Laboratory Practice
- Self-inspections
- Change management
- Investigations - deviations and CAPA
- Complaints, quality defects and recalls
- Training
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.
Why Choose NSF
Bring your questions and tap into the great experience and knowledge from helpful tutors. In addition, this course offers:
- Tutors with real credibility and experience to bring pharmaceutical GMP training to life with examples and real-life stories
- Training designed to reach all learning styles and preferences
- Detailed reference material to take away and to become instantly useful
This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95 percent of delegates rating it very good or excellent. It also meets the entry-level GMP training requirement for our popular pharmaceutical quality systems auditor/lead auditor training program so that you can continue your training journey with NSF.
Course Tutors
Course tutors will be selected from the following:
Kay Hukin - Kay is a PhD microbiologist, a member of the Royal Society of Biology, and eligible to act as a Qualified Person under the permanent provisions. She has over 20 years of experience in pharmaceutical quality across manufacturing, packaging, and testing for commercial and investigational medicinal products. Before joining NSF in August 2024, she served as Quality Director at a contract development and manufacturing organisation. Her background spans QC, QA, and manufacturing for oral solid dose, oral liquids, and sterile products for both commercial supply and early-phase or clinical trial use. She has extensive experience in manufacturing, packaging and labelling, facilities and systems implementation, technology transfer, outsourcing as both contract giver and acceptor, and importation across the EU and third countries. She also brings strong expertise in compliance and efficiency improvements to enhance right-first-time performance and reduce cost of quality. Kay is an experienced international QA auditor of manufacturers, suppliers, and distribution hubs in the UK, Europe, and India. Her areas of expertise include solid, liquid and sterile manufacturing operations, early-phase development and IMPs, quality management systems, microbiology laboratory controls, supply chain and vendor management, regulatory compliance, and QP development, training and mentoring.
David Waddington – David has broad experience in QA and manufacturing management, working with various dosage forms for global supply, including solids, liquids, sterile products, food supplements, and natural products.
Catherine Kay – Catherine has extensive pharmaceutical operations management, technical and QA experience spanning more than 23 years, gained working for a major international pharmaceutical organization, a start-up manufacturing organization and, most recently, a contract manufacturing organization in a corporate operations role.
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