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Regulatory Affairs Training
CS Executive Group can assist your Company in becoming compliant with TGA, GMP and PIC/S. Our Consultants can provide training to your staff at all levels including management, sales, laboratory, and production. Training presentations can be customised to include greater detail, address specific business need and requirements. Training may be held on-site or at our Training Centres. The courses listed below can be utilised by companies as introductory training or as refresher courses.
- Introduction to the TGA.
- GMP and PIC/S.
Striving for Quality
Since the 1970s a new awareness has been incorporated into the business world. This new principle is quality and this has manifested itself as ‘striving for quality’. Companies have spent vast sums of money on quality. Hopefully, for the right reason – to give the customer what they want.
Often in the past, companies gave the consumer what they wanted to give them, not what they were asking for. A modern company with this attitude or culture would not survive today (except by luck or if there are no competitors). The problem with following this outdated principle – and it is still done in developing markets though we would not dream of doing it in our own backyard; is that sooner or later there will be competitors. People hate to see a captive market – governments actually legislate against it. If you have treated your customers shabbily, because there was no competition, you will invariably pay the price when competition arrives. That is, if the competition offers a better service.
The principle of quality is a management practice that is applicable to all organisations including service organisations. What is a laboratory? A service provider. The service it provides is the data or information that it generates by performing analysis on a sample. This applies to the whole spectrum of laboratory types.
In an organisation, quality should now be developed to the extent that it is an integral part of any facility that is serious about improving its productivity and providing better customer satisfaction.
The word quality goes hand-in-hand with management and hence we talk about quality management or Total Quality Management (TQM).
QC vs QA.
Laboratory Accommodation and Environment.
Methodology and Analysis.
Development, Selection, and Evaluation.
Materials, Media, Reagents.
Limits of Detection.
Errors, Uncertainties, Repeatability, Reproducibility.
Recording of Results.
Reporting of Results.
Reviews/Audits/Corrective Action and Purchasing.
Basic Laboratory Training
As our major cities continue to grow, so does the demand for housing, accommodation, hospitals, and infrastructure. The positive news is that the private sector and governments locally and nationally will look at investing to keep up with demand. In order to complete multi-billion dollar projects such as for example, the Metro Rail Tunnel in Melbourne or the WestConnex in Sydney companies in Australia will need to employ highly qualified personnel within the construction and engineering sectors.
A laboratory is normally requested to determine the composition of a material or product. The analysis of materials is the means by which a company determines that their product meets the quality criteria expected by the consumer.
All laboratories, no matter what type, provide a service that is based upon an analytical function. The basis of any modern-day laboratory is analysis. For a chemistry-based laboratory, we are generally talking about chemical analysis.
Chemical analysis can be described as the determination of the chemical composition or make-up of a sample via a series of laboratory operations. This seems a very broad description so the analysis is divided into two arbitrary areas:
– Wet chemical (classical) techniques; and,
– Instrumental techniques.
This can be divided further into qualitative and quantitative analysis.
Gas Chromatography (GC).
GC/Mass Spectroscopy (GC/MS).
High-Pressure Liquid Chromatography (HPLC).
Atomic Absorption (AA).
Inductively Coupled Plasma (ICP).
IR, FTIR, UV/Visible.
Refractive Index (RI).
Nuclear Magnetic Resonance (NMR).
Technical Report Writing
It does not matter where you work, eventually, you will be required to write a technical report or business document. Technical reports, proposals, certificates of quality, test methods, working instructions, safe working practices, and so on are all considered technical documents and are a fundamental requirement of a company.
The purpose of this course is to provide you with the basic information you need so that you can develop your own style when writing technical documentation. The secret to writing good technical documentation is to prepare and present it in such a way that it is easy to read and follow. Remember, you are writing the document to communicate to someone else, whether they are internal or external to your company.
Have you ever thought about the cost of writing a report? When viewed realistically, writing documentation is an expensive process. You cannot afford to do it poorly when you look at the costs involved.
Scientists, as a general rule, do not meet the psychology profile of the creative/artistic type person who flourishes when writing. Give the scientist facts and figures, but do not ask them to write about them. The problem is, people do have to write about their results. Though they may not like it, it has to be done.
Why do technical people find it difficult to write reports? They have been well educated and a lot have spent six or seven years at university. Generally, you could say that there is a certain level of intelligence involved – so why does it not show when a report has to be written.
Is it a problem that exists where it just appears as though we are unable to write clearly. Has the education system been lacking? Was there sufficient importance placed upon presenting reports at school or university?
What is a Technical Report?
Reviewing Basic Writing Skills.
Enhancing Your Report.
Report Writing Strategies.
One Page Reports.
Analytical Test Reports and Certificates of Quality.
Test Method Writing.
Summaries of Working.
Instructions, Procedures, etc.
Safety in the Laboratory
Safety in the laboratory is an individual and personal responsibility, as well as a manager’s duty. Staff training should be directed towards making safety considerations an attitude of mind and an integral part of all work procedures.
No document can ensure safe practice within the workplace. Safety is dependant on the:
– quality of the previous training and experience of its employees;
– testing and labeling of the chemicals which are available;
– design and maintenance of the physical facilities of the workplace; and.
– reliability and safety of the equipment provided.
This course is written with the aim of making staff aware of the potential hazards involved with chemicals in the workplace and to instill in them the need to think about what they are doing.
Therefore, it is essential that all staff be made aware that the use of chemicals and equipment in a work environment is potentially dangerous. Staff should take all possible steps to minimise and guard against accidents and adopt safe work practices at all times. It is important that all laboratory staff adopt a new analytical psychology. This psychology necessitates them becoming totally aware of the work process they are performing and understanding the techniques and chemicals they are using, to minimise the chances of human error.
Working in the Laboratory.
How Chemicals Harm Us.
Poisons and Carcinogens.
General Laboratory Equipment.
Good Laboratory Practice
In Australia, there is a Standard AS 2830 – Good Laboratory Practice (GLP). This Standard sets out the requirements for technical competence and proper management of chemical analysis laboratories. The standard covers a variety of topics:
– Laboratory Organisation;
– Safety Assurance;
– Laboratory Facility;
– Testing and Measuring Equipment;
– Apparatus and Reagents;
– Test Methods and Procedures;
– Samples and Test Data Storage; and,
– Inspection and Assessment.
The Standard is designed to ensure that all data generated in a laboratory is technically sound and of the highest quality. Each section is important, but the production of quality results by a facility depends upon the implementation of ‘good practice’ in all laboratory procedures.
The utilisation of this standard assures the client that the laboratory is competent. Once implemented, the laboratory must audit and assess its processes and systems to ensure that it continues to meet the client’s requirements. Failure to do so tends to cause the facility to ‘fall behind’ and lose the competitive edge that such a system is designed to produce.
Quality Assurance System.
Testing and Measurement Equipment.
Apparatus and Reagents.
Test Methods and Procedures.
Calibration of Test Data Storage.
Inspection and Assessment.
Working in a Laboratory
What does it mean to be a scientist or technician in a laboratory? Why do laboratory staff ask questions such as what is that substance and why does it react that way?
Since the beginning of time, man has been seen as an inquirer. We are always trying to discover new things, classify everything and to understand the behaviour of things. The ability to enquire is one of the most important assets a person in a laboratory can have. You need to be able to act in the role of an inquirer when working in a laboratory environment.
The idea of this course is to give an introduction to working in a laboratory. It is hoped that people become aware of their role and function in a laboratory environment. Whatever the function of the laboratory, it’s most important asset is the staff and how those staff perform. This course presents people with the basics to become an integral part of the laboratory and assist the facility to generate data that are of high quality and scientifically reliable.
Types of Laboratories.
Laboratory Administration Processes.
Time Management in the Laboratory.
Laboratory Customer Service.
Classical Wet Chemical and Instrumental Analysis.
Recording and Review of Results.
Errors, Uncertainties, Repeatability and Reproducibility.
Reporting of Results.
Training at our Premises
CS Executive Group Inc. ChemSkill offers a range of Technical Training Services at any of our locations around our local and International locations. This service should be considered when a small number of employees will be undertaking the training course. All participants will receive morning tea, lunch, and training materials during the session.
On-site training is popular and should be considered when three or more employees are interested in a course as there are technical and financial benefits when the course is presented at the client’s facility. ChemSkill offers clients the option of having any of our courses presented on-site. This offers your Company the benefit of still having access to your staff during breaks, savings on travel expenses and most importantly cost savings as the fee is fixed on a daily basis rather than the number of attendees.
Training Course Price List and Conditions
Courses held at Client’s premises, within metropolitan Melbourne and Sydney incur standard fees which can be provided to you by contacting ChemSkill. All rates will incur 10% GST.
* No limit to the number of attendees.
For courses held at Client’s premises, outside metropolitan Melbourne and Sydney, our rates will also incur travel costs i.e. air and taxi fares, accommodation, meals, etc if required and travel time depending on location (i.e. if it is necessary to travel interstate the day prior to the course then there will be a travel time component included to allow for time away from the office).
Please Note: Training invoices must be paid in full prior to the commencement of the on-site training. In the event that the client cancels the scheduled course and there have been outlays such as airfares and printing of materials that are not transferable, then the client will agree to reimburse CS Executive Group for such expenses.
CS Executive Group are now offering scientific and technical training courses on-line with customised appraisal systems to ensure that your staff have achieved certain levels of understanding.
Benefits of online training:
- – Reduced costs: no travel required, no dedicated instructor, no facility rentals etc.
- – Start-up Speed: Online courses can be ordered and begun in under 24 hours.
- – Employees can learn onsite or in their own homes.
- – Flexibility: Courses can be taken at anytime, at work, home or elsewhere. Courses can be taken all at once or in short sections.
- – Increased knowledge: Technology-enhanced learning with sound, video and interaction has been proven to increase knowledge retention over conventional classroom instruction.
- – Comprehensive documentation: Course Examinations document record of employee understanding.
If you would like more information, please visit the online training courses web site.