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Qualified Person (QP) Role and Professional Duties of the Qualified Person training course

This 3-day Qualified Person (QP) Roles and Professional Duties training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of the role of the Qualified Person, as well as other Management personnel, to ensure compliance to GMP. The course meets all of the requirements of the UK Study Guide for trainee QPs.
Key InformationMake Booking

 

This 3-day Qualified Person (QP) Roles and Professional Duties training course provides trainee Qualified Persons and other pharmaceutical quality professionals with a thorough knowledge and understanding of the role of the Qualified Person, as well as other Management personnel, to ensure compliance to GMP. The course meets all of the requirements of the UK Study Guide for trainee QPs.

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 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.

By the end of this module, you will have a comprehensive knowledge of the role and duties of a working Qualified Person, as well as having a detailed knowledge of the requirements of EU GMP and GDP.

Key topics covered:

  • QP – Legal and Routine duties.
  • Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements and QP responsibilities.
  • Rules associated with the import and export of medicines.
  • QP Declarations for Active Pharmaceutical Ingredients (APIs) and Investigational Medicinal Products (IMPs).
  • The obligations of authorisation holders.
  • The requirements for complaints, recalls and investigations.
  • QP batch disposition.
  • Regulatory considerations.
  • Leadership for the QP.
  • Application form and viva practice.
 

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Booking details

Select the tabs below to find out all the details you need to know to make a booking on this Qualified Person (QP) Role and Professional Duties of the Qualified Person training course

Course cost

The cost of the Qualified Person (QP) Role and Professional Duties of the Qualified Person training course is £1950, 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:

  • Electronic 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.  The course also goes into detail of many of the main requirements of European Union Good Manufacturing Practice (EU GMP), and so 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 overview:

  • The Legal and Routine duties of a Qualified Person as described in EU GMP Annex 16.

  • How to interpret and apply the various International Conference on Harmonisation (ICH and VICH) guidelines.

  • The key factors, product or process information or metrics that confirm that a batch of pharmaceutical product is suitable for certification and has been made to GMP.

  • The principles and practice of current GMP as described within the GMP guidance including the Human Medicines Regulations 2012 and EudraLex.

  • The conduct and obligations of authorisation holders.

  • The GMP requirements for the import and export of medicinal products to GB and Northern Ireland

  • The conduct and obligation of Clinical Trial Sponsors and Investigational Medicinal Product providers.

  • The role of the Pharmacovigilance QP and interactions with the batch release QP.

  • The preparation and management of Regulatory Inspections.

  • The requirements and responsibilities of the QP regarding Active Substances or Investigational Medicinal Product declarations.

  • The requirements for QPs when acting as independent contractors or on behalf of third parties.

This course is run in partnership with QP Quandary.  You can book from this website or from their website.

If you are interested in booking, click on BOOK NOW above.

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

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Webinar: Microbiological control in pharmaceutical production 

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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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