Course Overview

  • “Great delivery of material. Lecturers made a difficult topic enjoyable and digestible.” Jonathan Luter / Reckitt Benckiser, UK
  • “I have enjoyed thoroughly the second part of the course. Great to summarise content knowledge and learn new aspects around formulation. Teamwork exercises are invaluable.” David Pysznik / Baxter Healthcare, UK

This intensive, interactive four-and-a-half-day pharmaceutical training course is designed to provide aspiring Qualified Persons and other pharmaceutical professionals with the knowledge they need to be able to understand the key quality requirements of parenteral products, inhalation products and topical medicines. We will teach you the important formulation requirements for each of these products and how those requirements influence the performance of the medicine in the body. We will also teach you the key processing steps in the production of these dosage forms, critical process control points and process monitoring requirements and, very importantly, what can go wrong during processing and the potential consequences for the safety, quality and efficiency of the medicine.

Reigster

About This Course

Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.

This course addresses the two important activities of formulation and processing and provides key information on:

  • How the physico-chemical attributes of the drug and the therapeutic indication influence:
    • Route of administration
    • Dosage form
  • Assuring bioavailability
  • Methods of manufacture of the major dosage forms
  • Factors affecting suitability for use of the major dosage forms

The Qualified Person, and other key technical personnel, MUST have a detailed understanding of these topics if they are to…

  • Assist in the design and implementation of relevant and effective quality systems for dosage form manufacture
  • Contribute to the RISK ASSESSMENT process for processing changes and unplanned deviations
  • Assess the adequacy of cleaning strategies
  • Assess the potential impact of changes to physical and chemical attributes of starting materials

This course is approved by the Royal Society of Chemistry as suitable for their members’ CPD.

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • The principles of drug design and formulation and the impact of even minor modifications on bioavailability/bioequivalence
  • The various processes involved in the manufacture of major dosage forms; tablets, capsules, oral liquids, topical liquids, creams and ointments, sterile products and inhalation products
  • The GMP issues and challenges for the Qualified Person to enable informed release decisions
  • How to apply the knowledge to: Risk management
    • Risk assessment
    • Problem solving and decision making
    • Auditing

Course Outline

Parenteral Products

  • Routes of administration
  • Formulation considerations
  • Major processing methods
  • Critical process steps
  • Key GMP requirements

Site visit to aseptic facility.

Inhalation Products

  • The respiratory route of administration
  • Formulation considerations
  • Major processing methods
  • Critical process steps
  • Key GMP requirements

Topical Products

  • The dermal route of administration
  • Formulation considerations
  • Critical process steps
  • Key GMP requirements

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!
  • Pragmatic training by experienced consultants supported by key academic staff from the University of Strathclyde, one of the UK’s top Schools of Pharmacy

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within 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

Find out why you should choose NSF for your QP training by visiting our qualified person training section.

Course Tutors

All course tutors each have a minimum of 25 years’ hands-on experience in the manufacture of every major dosage form. APIs, biologics, tablets, liquids, creams, ointments, sterile as well as non-sterile dosage forms – you name it they have made it.

Course tutors will be:

Course Fees

Course cost (excluding VAT)  £3,230.00

DISCOUNTS AVAILABLE

Multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities – contact us for details.

Have a question or want to book a place? Contact QPpharma@nsf.org - you can also register online by clicking below.

Register

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