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.
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.
Upcoming start dates
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.
- 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
- HPLC, GC, SEC, TLC
- Proof of structure methods
- Mass Spec., NMR
- Biological assays
- ELISA, PCE and SDS Page
Course delivery details
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.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 5
Very knowledgeable and energising tutors. Teamwork sessions were invaluable for learning. Loved the scenarios.
Expenses
Discounts
Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.
I have a much greater awareness of the range of analytical techniques available as well as where and when to use them.