Course summary
4.5 days
3,150 GBP excl. VAT
Full time
Online courses
Next available date: 09/11/2020 08:45 - Online courses

Course description

Analysis and Testing

This highly focused, intensive four-and-a-half-day course, taught by leading scientists and former Quality Control Managers, is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to be able to perform their duties with skill and competence when interacting with the Quality Control laboratories. We will explain to you the strengths and limitations of analysis and specific analytical methods, we will advise you on how to apply the principles of quality management and GMP to the testing environment in a pragmatic, effective way, and we will advise you of the very latest “hot topics” with the regulators and how to ensure that your laboratories are in compliance.

Virtually all patient and business critical decisions made by Qualified Persons and other quality professionals are in some way made on the basis of data provided by an analytical laboratory. It is, therefore, of paramount importance that this data is accurate and can be relied upon; in recent years data integrity has become a very ‘hot topic’. Hence, it is essential that these decision makers understand the basis of the analytical techniques used and their respective strengths and weaknesses.

This module seeks to provide a foundation of knowledge which will enable Qualified Persons and others to judge analytical data, ask relevant questions to aid interpretation and know when to call for additional data/advice. This knowledge is also essential when auditing laboratories.

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

If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - 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 other 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 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.

Outcome / Qualification etc.

Key Learning Objectives:

  • To understand the essential components of a laboratory management system that can ensure data integrity
  • To understand the philosophy and principles of pharmaceutical analysis
  • To understand the basis for commonly used analytical techniques
  • To provide acting and trainee QPs with sufficient understanding of pharmaceutical analysis to enable them to have effective dialogue with the laboratories providing them with data

Training Course Content

Course Outline

Laboratory Management Systems

  • Principles of GCLP/laboratory management and data integrity
  • Handling OOS/OOT results

Philosophy and Principles of Analysis

  • Sampling methods/regimes
  • Analytical validation and method transfer
  • Equipment maintenance and calibration
  • Stability testing – protocols and methods
  • Pharmacopoeia and monographs

Analytical Techniques

  • ‘Classical’ methods of analysis
  • PH, Karl Fischer
  • Physico-chemical testing of solid dosage forms
  • Hardness, friability, dissolution
  • Spectrophotometric methods
  • Infrared, ultraviolet and atomic spectroscopy
  • Chromatographic methods
  • Proof of structure methods
  • Mass Spec., NMR
  • Biological assays
  • ELISA, PCE and SDS Page

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Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Average rating 5

Based on 2 reviews

Ethan Baldry, Quotient Clinical, UK
I have a much greater awareness of the range of analytical techniques available as well as where and when to use them.
Lynsey Niblett, BCM Specials, UK
Very knowledgeable and energising tutors. Teamwork sessions were invaluable for learning. Loved the scenarios.
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Case Study
The Journal by NSF Health Sciences
NSF International, Pharmaceutical Services

NSF Health Sciences have produced a number of journal articles that are released a number of times throughout the year. Here you can download some of the latest articles.

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