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Qualified Person/QP Training Course: The role and professional duties of the Qualified Person

This intensive 3-day 'live online interactive' course provides Pharma professionals with a thorough knowledge and understanding of the role and duties of the Qualified Person. The course meets all of the requirements of the UK Study Gude for QP's.
Key InformationMake Booking

Our intensive 3-day QP roles and professional duties training course is aimed at people who need an in-depth appreciation of the role and duties of a QP related to the manufacture and distribution of medicinal products for human and veterinary use. 

The role of the Qualified Person (QP) is a complicated one, and it can easily be assumed that they need to “everything” before a batch of product can be released onto the market.  This is not the case, and whilst we will not make the role of the QP easier, we will hopefully make the roles and duties of a QP clearer, so that they can focus on what is legally required in order to certify a batch of product prior to release, whilst keeping within the law and satisfying any legal and professional obligations.  This three-day virtual course covers the role and professional duties of the QP 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 anyone working in Quality Assurance, especially those who have roles in reviewing batch records, and any associated problems and deviations, ahead of batch release.

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  info@inspiredpharma.com . To see our full range of in-house courses and customisation and delivery method options please visit this page.

    Booking details

    Select the tabs below to find out all the details you need to know to make a booking:

    Course cost

    The cost of the QP role and professional duties 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

    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 Quality Assurance batch-release related roles.  As a large part of the course covers the requirements of European Union Good Manufacturing Practice (EU GMP), this course can also be viewed as an Advanced GMP training course to supplement any in-house GMP training that potential delegates have undertaken in the past.

    Course times:

    09.00 – 16.30 each day

    Course overview:

    This course provides an extensive guide to the roles and responsibilities of the Qualified Person (QP).  It provides a detailed explanation of the legal requirements for a QP, as well as their routine duties.  The course covers not only the role of the commercial QP, but also the Clinical Trials QP and Pharmacovigilance QP as well.  In addition, we cover that the QP is not “all alone”, and that there are other key personnel defined in GMP, such as the Head of Production, the Head of Quality Control and Senior Management that also have responsibilities defined in GMP, essential to ensure that the patient, or the end user, gets safe and effective product of the right quality.

    The course also includes the requirements of the 9 chapters of European Union GMP, as well as a high-level overview of the annexes.  This is essential knowledge for a QP, as they will need to know that a batch meets the requirements of EU GMP as part of any batch certification process.  The course will also give very useful information for anyone involved in supporting a QP, ahead of batch release, on what information is needed to allow a QP to certify that a batch meets the requirements of GMP as well as its Marketing Authorisation (Product Licence) requirements.

    Course content:

    Click on the +icon for more details on each topic:

    THE LEGAL REQUIREMENTS OF A QUALIFIED PERSON:

    • An overview of existing European and UK legislation.
    • The legal duties of a QP.
    • Marketing Authorisations and Manufacturer’s Authorisations for human and veterinary medicines.
    • The role of the QP with regards to declaration of Active Pharmaceutical Ingredients (APIs).
    • Key factors, product or process information or metrics that confirm that a batch of pharmaceutical product is suitable for certification.
    • Clinical trials, personnel involved, Investigational Medicinal Products (IMPs) and the IMP QP.
    • The Pharmacovigilance QP (QPPV).
    • The contract QP.
    • The ramifications of BREXIT.
    • Movement of goods into Northern Ireland

    THE DUTIES OF THE QUALIFIED PERSON:

    • The duties of key personnel described in EU GMP – the Head of Production, Head of Quality Control and the Qualified Person and the role of Senior
    • The responsibilities of a
    • The role of Quality Assurance
    • The structure and content of EU GMP Annex 16 (Certification by a Qualified Person and Batch Release).
    • The role of the QP with regards to import and export of products (EU GMP Annex 21).
    • The difference between QP certification and batch release.
    • The UK QP professional bodies and their Code of Practice for QPs.
    • How you become a QP in the UK.
    • The Qualified Person (QP) Study Guide and its requirements.
    • The link between the professional bodies and the regulatory authority (MHRA and VMD).
    • Disciplinary procedures.
    • Continuous Professional Development requirements for the QP.

    THE MHRA’S RULES AND GUIDANCE FOR PHARMACEUTICAL MANUFACTURERS AND DISTRIBUTORS

    • The history of the Orange Guide.
    • The structure of the current Orange Guide and its contents.

    EUROPEAN UNION GOOD MANUFACTURING PRACTICE

    • The history of EU GMP.
    • Eudralex and its structure, content and legal status.
    • The structure and legal status of EU GMP.
    • An overview of UK and EU legislation, including Human Medicines Regulations 2012 and corresponding European Directives and Regulations.
    • The GMP Directives, Chapters and Annexes.
    • EU GMP Parts 1, 2, 3 and 4.
    • The International Council for Harmonisation (ICH) and Veterinary International Council for Harmonisation (VICH).

    EU GOOD MANUFACTURING PRACTICE REQUIREMENTS – CORE ACTIVITIES:

    • An overview of the nine chapters of GMP and their requirements.
    • Suppliers and control of incoming materials.
    • The requirements for Active Ingredients and Excipients.
    • The role of the QP with regards to declaration of APIs.
    • Pharmaceutical supplier standards.
    • The role of Purchasing.
    • The warehouse operation.
    • Production and Packaging.
    • Sampling, testing and Quality Control.

    EU GOOD MANUFACTURING PRACTICE REQUIREMENTS – SUPPORT ACTIVITIES:

    • Documentation and records.
    • Validation, qualification and change control.
    • Calibration and maintenance.
    • People and training.
    • Complaints, quality defects and recalls.

    EU GOOD MANUFACTURING PRACTICE REQUIREMENTS – THE ANNEXES:

    • A high-level overview of the annexes to EU GMP and their role.
    • Recent and future planned updates to the chapters and annexes.

    UNITED STATES GMP:

    • An introduction to United States GMP.
    • USA pharmaceutical legislation.
    • United States GMP (21CFR Parts 210 and 211).
    • The Food and Drug Administration (FDA).
    • FDA inspections.
    • FDA Guidance documents.
    • The main differences between EU and USA GMP.

    THE QUALITY MANAGEMENT SYSTEM:

    • The need for a Quality Management System (QMS).
    • The QP’s reliance on the QMS.
    • Quality Risk Management (ICH Q9).

    BATCH REVIEW, RELEASE AND REGULATORY INSPECTION:

    • The process for passing, rejecting and releasing a batch of product.
    • Review of batch records and other pertinent information.
    • Who can perform this review?
    • Having the assurance that a batch meets GMP and legal requirements.
    • Preparation for and management of regulatory inspections.

    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?

    Expert Tutors

    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.

    Christine started her career with Sanofi Winthrop working in QC over 20 year’s ago, moving through to the QA Department and from there into QP training as her career progressed, finally working as Head of Quality.  She has extensive experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms.  She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally

    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

    See below the wonderful feedback across our course range:

    Find out about our course ranges

    GMP Training

    QMS Training

    GDP/RP Training

    GMP Compliance

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    GDP Compliance

    Annex 1 2022 Section 10: Quality Control (QC)

    This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

    Annex 1 2022 Section 9: Environmental and Process Monitoring

    This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

    Annex 1 2022 Section 8: Production and Specific Technologies – part 3

    In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

    Annex 1 2022 Section 8: Production and Specific Technologies – part 2

    This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

    Annex 1 2022 Section 8: Production and Specific Technologies – part 1

    This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

    Annex 1 2022 Section 7: Personnel

    In this article, we move onto the personnel section, section 7.

    Annex 1 2022 Section 6: Utilities

    In this article we expand upon the equipment section but looking at Utilities as described in section 6.

    Annex 1 2022 Section 5: Equipment

    In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

    GMP News and Articles

    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.

    Quick Links

    Find your way quickly to any part of our website by selecting any of the links in this section:

    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 began to once again offer traditional classroom courses - see details on each course page.

    Click on course name for full course details and dates:

    Pharmaceutical GMP Auditor/Lead Auditor

    Advanced Good Manufacturing Practice

    Good Distribution Practice

    Good Manufacturing Practice

    Internal Auditor

    GMP Problem Solving

    Responsible Person (RP)

    Sterile Products

    QP Courses - full range

    See and download our Auditing Brochure detailing our courses and services in this important area.

    Online courses available anytime anywhere 

    Data Integrity

    Good Distribution Practice (GDP)

    Good Manufacturing Practice (GMP)

    Pharma Quality Management Systems module

    QP Medicinal Chemistry & Therapeutics module 

    QP Quality Management Systems module

    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.

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