About This Course

In an ever-changing pharma world, it is a challenge for QPs and prospective QPs to gain a functional understanding of the equipment and processes used to manufacture and test today’s dosage forms. This Royal Society of Chemistry approved course provides hands-on experience to trainee QPs wishing to gain a better understanding of what really happens in manufacturing and testing. As part of your practical QP training, you’ll gain knowledge from industry and academic experts and solve real-life QP problems.

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

Key Learning Objectives

On completion of this course, delegates will:

  • Have experienced totally practical, hands-on lab-based training at one of the top schools of pharmacy in the UK
  • Understand the “why” behind key pharma industry processes
  • Become closer to products than is possible in a Good Manufacturing Practice (GMP) environment
  • Grasp the impact of starting materials and risk-based supplier management programs
  • Gain a practical understanding of sterile products, tablets, continuous processing and analysis

Course Outline

Sterile Products

  • Manufacture a terminally sterilized injection
  • In-process controls and environmental monitoring
  • Inspection, analytical testing and sterility testing
  • Find out what’s really critical

Tablets

  • Wet and direct compression technique
  • In-process controls
  • What goes wrong and the challenges faced by the QP
  • Critical control points

Continuous Processing

  • Introduction to continuous processing techniques and philosophy
  • Consideration of continuous processing and batch processes and their control
  • Continuous processing for product manufacture
  • Continuous processing for starting material and application programming interface (API) manufacture

Analysis

  • A range of analytical techniques to test raw and finished products
  • QP information to make decisions
  • Understand your analyst

Discussion and Working Groups

A significant proportion of our practical QP training course time is devoted to group work where delegates have the opportunity (through case studies) to put theory into practice. Additionally, discussion periods and tutor panel sessions provide delegates an opportunity to obtain answers to their specific questions and concerns.

Who Should Attend

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

  • Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.<\li>

Course Tutors

Course tutors will be selected from the following:

Mike Halliday - Mike has extensive experience as a hands-on tablet compression manager and manufacturing manager responsible for solid dose, liquids, creams and ointments, and aseptic manufacturing for major multinationals.

Erika Notman - With over 25 years’ experience in the production and control of pharmaceuticals, latterly working within a CMO, Erika has worked with sterile and non-sterile products as a QP and in worldwide QA. She is passionate about the need to establish excellent working relationships throughout company operations.

Oona McPolin - Oona is a specialist in pharmaceutical analysis with over 20 years’ experience working in cGMP pharmaceutical laboratories. She is an expert in a range of analytical chemistry topics, including data integrity; development, validation and transfer of analytical methods; and HPLC.

David Waddington - David has over 30 years’ experience in QA roles supporting the manufacture of a wide range of different dosage forms for global supply including solid dose, liquids, sterile and natural products.

Plus tutors from the University of Strathclyde’s School of Pharmacy.

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.