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:
Samantha Clack - A working QP, lead auditor and QP trainee coordinator, Samantha has an up-to-date knowledge of GMP requirements and hands-on experience implementing and meeting regulatory expectations.
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.
Rachel Carmichael – Rachel has nearly 30 years GMP experience, including acting as an MHRA Inspector for over 10 years. Eligible as a Qualified Person, Rachel has broad understanding of the many different ways with which companies are capable of complying.
Pharmaceutical GMP Audits and Self-Inspections
Investigational Medicinal Products - QP Module
A-Z of Sterile Products Manufacture
Additional Recommended Courses
Responsible Person and Good Distribution Practice (Cogent Gold Standard Approved Training)
An interactive good distribution practice (GDP) and responsible person training course, focusing on the key requirements for the distribution and storage of pharmaceutical products and materials, which will enable delegates to understand and effectively implement the principles of GDP at their facilities.
This Cogent-approved course will be presented virtually through a combination of self-paced learning hosted on our Learning Management System and four half-day virtual classroom sessions. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutor: Samantha Clack
Price: £1980 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities and NHS staff are entitled to a 20% discount. (Proof will be required).
Pharmaceutical GMP
This highly interactive virtual pharmaceutical GMP training course will teach you how to apply pharmaceutical GMP in your workplace and keep you up to date with industry requirements. The course provides an excellent opportunity to share your GMP questions with experienced industry experts and hear their solutions first-hand.
This virtual instructor-led training course is delivered over two consecutive days and will be managed through our online Learning Management System. Full details will be emailed following registration.
Tutor: Rachel Carmichael
Price: £780 excluding VAT (where applicable)
Please note: payment by credit/debit card will be required at time of booking.
You can view our booking terms and conditions from here.
Quality Risk Management
A highly interactive course designed to provide you with the tools and techniques to improve your decision-making skills and better protect your company and the patient. This course addresses both proactive and reactive risk management. We will show you how to take a structured, risk-based approach to problem-solving and decision-making, using techniques such as failure mode effect analysis (FMEA), hazard analysis critical control point (HACCP), 5 whys and fishbone diagrams. You will practice resolving real-life scenarios and case studies using these tools to great effect. In short, we will provide you with the skills and tools to turn data into information and improve decision-making at work!
Tutor: Rachel Carmichael
Price: £780 excluding VAT (where applicable)
Please note: payment by credit/debit card will be required at time of booking.
You can view our booking terms and conditions from here.