Qualified Person/QP Pharmaceutical Quality Systems Training CourseThis intensive 3-day 'live online interactive' course provides Pharma professionals with a thorough knowledge and understanding of GMP-based Quality Management Systems. The course meets all of the requirements of the UK Study Gude for QP's. Key InformationMake Booking
Our intensive 3-day QP Pharmaceutical Quality Sytems training course is aimed at people who need to have a thorough knowledge and understanding of GMP-based Quality Management System involved in the manufacture and distribution of medicinal products for human and veterinary use.
It is essential that any pharmaceutical quality professional has a detailed appreciation of the workings of a GMP based Quality Management System. This three-day virtual course covers how to establish, monitor, manage and improve a Pharmaceutical Quality Management System (PQMS) and is based on and includes all of the requirements of the latest UK: Qualified Person Study Guide for trainee QPs. The course is primarily aimed at trainee QPs, but will also be of great benefit to any new Quality Manager who needs a greater appreciation of how to have a GMP compliance based Quality Management System that not only meets the requirements of GMP, but also the satisfies the needs of the business as well.
Key features of our 3-day course
Maximum class sizes
For maximum interactivity and effectiveness, our class size is limited to 10 delegates with at least two tutors. The quality and effectiveness of our courses is unrivalled.
Value for money
Our 3-day course is priced at £1995 – much lower than other alternatives. And with no extra costs of travel, hotels and meals it offers the best value in the marketplace.
Fully up-to-date including BREXIT
This course is totally up-to-date with all recent legislation and in particular the impact of Brexit.
Lively and highly interactive course
Our 3-day format is designed to ensure that this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses in this article.
Take the course at home or your workplace
Avoid travelling to remote locations and staying in hotels. Focus your time on acquiring this critical knowledge and not in your car or the train.
Make a Booking
IN HOUSE COURSES – this course can also be delivered on your site or using our ‘live online interactive’ courseware on a date to suit you. If you are interested please contact us at firstname.lastname@example.org . To see our full range of in-house courses and customisation and delivery method options please visit this page.
Select the tabs below to find out all the details you need to know to make a booking:
The cost of the QP Pharmaceutical Quality Systems training course is £1995 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.
However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.
What's included in cost
The cost includes:
- Course folder containing copies of slides and supplementary notes and handouts.
- Course attendance certificate
- Full tutor support and access during course times.
Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.
If you plan to pay by credit card then you should first look at this helpful information.
Alternatively, if you want to discuss any aspect of this training course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.
Based Outside the UK?
If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.
Group Bookings - discounts of up to 50%
Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.
Key Course Information
Who will the course benefit?
This course is aimed at trainee QPs as well and anyone working in, or moving into, more senior roles with the Quality Department. It is ideally suited to Quality Assurance personnel who need to have a greater understanding of how to have a compliant, effective and efficient QMS working well within their organisation. The course is also of benefit to any manager working at a pharmaceutical organisation to understand their role in the overall QMS and how they can monitor and improve the performance of their own area as well.
09.00 – 16.30 each day
This course covers how to establish, monitor, manage and improve a Pharmaceutical Quality Management System (PQMS) that meets the requirements of Good Manufacturing Practice (GMP), as well as the requirements of the Internal Council of Harmonisation’s Guidance document on Pharmaceutical Quality System (ICH Q10) and the United States FDA’s Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations. The course looks at the traditional role of a PQMS, with a focus on product quality and protecting the patient or end-user, but also includes a modern contemporary approach, and includes many quality ideas from other leading sectors, including the requirements of the international standard for Quality Management Systems, ISO 9001. The course focuses on how to have a QMS that includes the requirements of GMP, but is also of value to the whole business, with a focus on improving effectiveness and efficiency throughout the whole system.
Click on the +icon for more details on each topic:
THE PHILOSOPHY AND BASIC PRINCIPLES OF QUALITY ASSURANCE:
- The evolving concept of Quality, Quality Assurance (QA), Quality Control (QC) and Quality Management System (QMS) thinking.
- The regulatory requirements for a Quality Management System.
- European Union and USA GMP requirements.
- An overview of the requirements of ISO 9001.
- The FDA’s Quality System Model and ICH Q10 for Pharmaceutical Quality Systems.
- The need for a QMS for the whole organisation.
THE DESIGN OF A QUALITY MANAGEMENT SYSTEM:
- The processes of a QMS and the products and services provided by the organisation.
- Documentation and record requirements, including Data Integrity.
- Establishing roles and responsibilities.
- Organisational structures and reporting relationships.
- The importance of training and development.
- Appropriate facility design and operation.
- The importance of validation, qualification, calibration and maintenance.
- Purchasing and control of incoming materials.
- Control of outsourced activities, including brokers, distributors and repackagers.
- Technical and Quality Agreements.
- Approval of suppliers and monitoring their performance.
- Production planning, scheduling and stock control.
- An overview of Computer Systems Validation (CSV).
- Avoidance of counterfeit and illegal activities.
- Having approved customers and the importance of Good Distribution Practice (GDP).
MONITORING A QUALITY MANAGEMENT SYSTEM:
- Establishing objectives and Key Performance Indicators (KPIs).
- Dealing with problems and use of Root Cause Analysis (RCA) tools and techniques.
- Deviation management.
- Correction, Corrective Action and Preventive Action (CAPA systems).
- Quality Risk Management and the role of ICH Q9.
- The role of internal and external audits and regulatory inspections.
- Managing changes and the importance of a change control system.
- Dealing with complaints and monitoring customer satisfaction.
- The recall system.
- The importance of Management Review and how to perform these effectively.
- Product Quality Review.
- Batch record review and batch release.
IMPROVING A QUALITY MANAGEMENT SYSTEM:
- The importance of leadership, delegation, communication and teamwork.
- Interpersonal skills needed for the management of the QMS.
- Analysis of performance data.
- Quality metrics and communication of these.
- Quality improvement tools and techniques.
- The role of the modern Quality Assurance department.
A proven and effective training delivery method
Live Online Interactive Training
This course is currently available using our proven and very popular ‘live online interactive’ format. Select the tabs below to find out more:
Stay Safe - Attend from home or whilst at work
With 2 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:
- chat online with the facilitators and other delegates
- raise your ‘virtual’ hand to ask a question
- participate anonymously in a poll or survey and see an instant display of the class results
- undertake exercises on your own or in a group
And best of all no travel is needed nor a stay in a hotel saving you a lot of time, hassle and money.
As always we will ensure this event is inspirational, enjoyable and educational.
What is involved?
We will send you a link to the live online interactive course with your joining instructions once you have booked your place.
You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.
Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.
Why choose Inspired Pharma?
Neil is an experienced Quality leader and Qualified Person with over 35 years of pharmaceutical industry experience. He has been a registered QP on several site MIAs and MIA (IMP)s for multiple dosage forms for human pharmaceutical medicinal products, including sterile products, solid dose and ATMPs. Neil also has experience of being a registered QP on a site Man(A) veterinary medicines licence. In addition, he has also acted as a successful QP Sponsor and particularly enjoyed this role.
As well as being a registered QP, Neil has also been named on both UK and Swedish GDP Licences as an RP, and gained substantial GDP knowledge across global supply chains.
During his career he has built extensive knowledge of European and Global GMP and GDP quality systems and has a successful record of team management, including internationally. He has worked for major pharmaceutical companies including GlaxoWellcome, Wyeth, Novartis, Allergan and Boehringer-Ingelheim Animal Health. Neil is also an experienced Corporate GMP Global quality auditor.
Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. He initially worked for Evans Medical Limited as a Production Development Scientist. He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.
Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations. He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world. He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.
Recent Delegate feedback
“Fantastic delivery, very engaging and informative” QA Officer
“Very engaging and informative” QA Officer
“Excellent content” QA Officer
“Tutor delivery was superb” QA Officer
“Excellent overview” Quality Compliance Officer
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Read our articles on GMP regulatory developments as well as news about our training courses.
About Inspired Pharma
We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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Our Public Course range
Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.
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Online courses available anytime anywhere
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.