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Pharmaceutical Microbiology MSC
Pharmaceutical Microbiology MSC
Distance Learning / Home or Workplace Study / MSc / Diploma / Certificate / QP Training / Module Credit
The Benefits
The PIAT Programme is designed to improve your work performance. An important benefit of the programme is that it provides you with the opportunity to achieve University qualifications without the need for prolonged absence from work. In the long term, it should help you to improve your career prospects by gaining industry qualifications validated by a leading University. It also provides the training required for Qualified Person recognition. For many in the Pharmaceutical and other industries CPD is now an essential component of career development and this can be enabled by subscribing to individual modules.
Modules
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Modules are presented as texts w ritten to enable y ou to understand the subject and to study at home or at work. Exercises are included in the text to help the learning process and you will undertake a written assignment dealing with aspects of the subject. Each module will require approx 150 hours of study time to understand the subject matter, to complete the module exercises and the module assignment and to attend the workshop and revise for the examinations.
Industrial Pharmacy
Industrial Pharmacy
MODULE 1
MODULE 5
MODULE 7
MODULE 8
Lean Processes Business Improvement, Statistical Science (New for October 2013)
This unit will help you to develop a practical understanding of the lean processes that can help a business be more efficient known as business improvement statistical sciences. It will raise your awareness, knowledge and capability in statistical techniques and frameworks so that business leaders, managers and experts are able to champion, support and engage in the effective use of these tools in their business process improvement initiatives and day to day activities.
MODULE 9
MODULE 14
MODULE 11
Quality Control Laboratory Testing - Laboratory testing of raw materials and finished products
This module covers the sampling, specifications, physical, chemical, spectroscopic, and chromatographic test methods, packaging component testing, microbiological testing, environment, water, steam and gasses, validation and out of specification results.
Clinical Trials
MODULE 1
MODULE 5
MODULE 2
Phase I
A key module for understanding early drug development, enabling the module participant to understand what can be defined as phase I trials, the pre-clinical data required by the regulatory authorities before first human dosing, how a phase I trial can be designed and data interpreted alongside risk mitigation. General pharmacokinetic and pharmacodynamic principles are dealt with in terms of phase I data analysis.
MODULE 4
Pharmacovigilance
This module provides an introduction to pharmacovigilance including key definitions and the nature and burden of adverse drug reactions (ADRs). It covers safety monitoring in clinical trials, what ADRs this will detect and its limitations. It goes on to look at the methods for post-marketing surveillance, introduces patient risk management and relevant ICH Guidelines and CIOMS reports.
Phase II
This module will provide a clear understanding of the planning and performance of phase 2 clinical trials, estimation of therapeutic dose and regimen, the importance of biomarkers in giving an early objective insight into likely therapeutic benefits, and decision trees for taking a drug into phase 3 clinical trials.
MODULE 8
Regulatory Issues
This module describes the major regulatory agencies and their committees, the approval procedures for clinical trial applications and the data requirements for their submission, the procedures for interaction with regulatory agencies in order to obtain scientific advice during the drug development programme, and finally, the procedures for submission of marketing authorisation applications.
In association with
MODULE 1
MODULE 5
MODULE 3
All modules on this page are assessed by assignments only (no written examination).
Pharmaceutical Microbiology
In association with
The Pharmaceutical Microbiology Interest Group (Pharmig) was established in 1991 and is a non-profit
making professional organisation based in the UK, that represents the interests of people who are working in, or having responsibility for (including the provision of commercial services), pharmaceutical microbiology.
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MODULE 1
MODULE 5
Water Aspects
This module will look at the Compendial Water Qualities used in the industry. The Design of Water Generation, Storage and Distribution Systems together with the options for Validation & Change Control, System Operation and Management and System Sanitisation will be reviewed. The Methods of Testing, including the Common Contaminants encountered as well as the Sampling Regimes & Techniques will be explained. Data Management, Trending and Interpretation will be covered.
MODULE 3
Application of Microbiology in Biopharmaceuticals Microbiological Environmental Monitoring & Control (sterile & non-sterile manufacturing areas)
This module examines the requirements of a robust and flexible environmental monitoring programme, which can be applied to both sterile and non-sterile manufacturing units. It includes an examination of the current Regulatory Requirements; an exploration of Environmental Monitoring Methodologies, including aspects of their Validation, together with a look at the Commonly Isolated Micro-organisms. Data Management and Trending including Basic Statistics will also be covered. A look at Risk Management of procedures, the role of Disinfectants and Rapid Methods will also be explored to enable the student to gain a balanced understanding of this key aspect of pharmaceutical microbiology.
MODULE 4
A review of the current Legislation & Guidelines in Biopharmaceuticals will be conducted. The module will cover Hygienic Plant Design and Sanitisation CIP/SIP. A detailed look at Biopharmaceutical Technology (growth techniques, cell & tissue culture, fermentation, purification, harvesting, final drug products) will be conducted. The Viral Load Reduction/Detection Techniques together with those available for Mycoplasmas will be explained. Lyophilisation Techniques as well as Test Methods for Biotechnology Products will be included.
MODULE 8
Antimicrobials
Disinfectants The current Regulatory Requirements for disinfectant use along with GMP Associated with Disinfectants will be covered in this module. The Types of Disinfectants and their Selection will be included covering aspects of Practical Usage. A detailed look at Test Methods and Validation will be described.
Preservatives
The Preservatives Available for Use in Mixtures, Suspensions & Syrups will be examined as well as the Preservation of Sterile Products. The test methods for evaluation of formulations such as Preservative Efficacy Testing and Stability of Drugs & Stability Testing will also be included. The Resistance towards Preservatives in Pharmaceutical Products will be mentioned.
Other Information
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University Awards
Module Credits are awarded for the successful completion of each module. Certificate is awarded for the successful completion of an approved set of four modules, normally within two years of registration. The Diploma of Advanced Studies is awarded for the successful completion of an approved set of eight modules, normally within four years of registration.
Study Requirements
Access to PIAT is open to all. There are no special entry requirements if you want to study individual modules as part of your personal development programme. PIAT is an advanced level programme and some modules require an advanced level knowledge of physical and organic chemistry, biology and mathematics. All modules require some work and experience within the industry. To study for a Diploma in Advanced Studies or the MSc degree you
The Master of Science Degree is awarded for the same study programme as the Diploma, with the addition of a dissertation on a workplace research project. In most cases the dissertation will deal with a subject that is relevant to your industrial experience and will require approximately 600 hours of study. Each dissertation project will have an academic supervisor who will have primary responsibility for the supervision of the dissertation work, and an industrial tutor. The industrial tutor will be an experienced person from your company. The subject of the dissertation project will be agreed between you, the academic supervisor and your industrial tutor. Workplace study facilities and supervision arrangements must be approved by the University. Assessment If you want to earn module credits towards a University award, your progress will be examined by completion of the exercises in the module, assessing your written assignment and by taking a two hour unseen examination at the University of Manchester. If you do not want the credits towards a qualification you do not need to take the examination. Note: Some modules are assessed by exercises and extended assignments only, without an unseen examination.
should normally have a degree level scientific qualification. If you do not already have the required qualifications to study for the Diploma in Advanced Studies you can join this programme when you have proved your ability by earning four module credits.
Timetable
Students can start the programme in either October or April. Examinations are held in Manchester over a one week period normally in March and September each year. New for 2013 is a Weekend Summer School, which will run at the end of June. Workshop sessions will run, covering all our modules and will be available to all students.
The summer school will give students the opportunity to meet and network with other students and tutors.
Registration
to purchase individual modules complete sections 1, 2, 3, 5, 8 and 9 of the PIAT Programmes application form. to apply to join the Certificate, Diploma in Advanced Studies or the MSc programmes complete all sections of the PIAT Programmes application form.
to apply to join the QP Training please download a separate application form from the following websites: http://www.primex.co.uk/iob http://www.rsc.org http://www.rpsgb.org.uk
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For further information on PIAT modules please visit our web site
PIAT, School of Pharmacy & Pharmaceutical Sciences, The University of Manchester, Room 2.19f Stopford Building, Oxford Road, Manchester M13 9PT Tel: +44(0)161 275 1798/2371 ( ) Email: piat@manchester.ac.uk Website: www.manchester.ac.uk/piat
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