UCert Pharmaceutical and Medicinal Product Manufacturing
01 Jan 2022 - 31 Aug 2028
| Course Leader | Suzanna Kean |
|---|---|
| Course Team | |
| Awarding Body | University of South Wales |
| Teaching Institutions | University of South Wales |
| Modes of Study | Part Time |
Document Version
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
QAA Benchmarks
Educational Aim
The main aims of the course are:
Overarching Course Aims
1. To provide education at undergraduate level in aspects of Production, Engineering, Quality and Validation that are relevant to those currently working in, or wishing to work in the manufacture of BioPharmaceutical/Medicinal Technology Products.
2. To provide education to give candidates a strong grounding in modern BioPharmaceutical/Medicinal Technology science and engineering concepts with a view to the Equipment, Processes, Facilities and Quality Systems used in the manufacture of medicines in line with the various worldwide regulatory and current Good Manufacturing Practices (cGMP) guidelines.
Overarching Course Objectives
• Provision of courses that allow employees working in the BioPharmaceutical/Medical Technology or other related industries, or wishing to move into the sector, develop the necessary knowledge and skills to perform effectively as a member of a Production, Engineering, Quality or Validation Team.
• Provision of a body of knowledge, practical, technical and theoretical, that is relevant to the needs of manufacturing medicines.
• Provision of the fundamental science underpinning the manufacture of medicines.
• Provision of courses that are recognized by and relevant to the industry
• Provision of high quality industrially relevant education and training by experts from academia and industry.
• Delivery of modules in a manner that is suitable for continuing professional development and life-long learning.
Overarching Course Learning Outcomes
• Have a detailed knowledge of the Manufacture of Medicines and a broad knowledge of the fundamental science and engineering underpinning this.
• Have a practical knowledge of the Quality Systems for the regulatory environment in which medicines are manufactured.
• Have demonstrated the ability to work effectively in a team across Production, Engineering, Quality and Validation.
Learning Outcomes
| A1 | Recognise the general scientific and mathematical principles that underpin the Pharmaceutical and Medical Product Manufacturing industry. |
| A2 | Recognise the technology/engineering base relevant to the Pharmaceutical and Medical Product Manufacturing industry. |
| A3 | Identify (show knowledge of) Quality Systems for the regulatory environment in which medicines are manufactured. |
| A4 | Recognise design, quality, and safety issues related to the manufacture of pharmacetucial and medicinal products. |
| B1 | Decide on a sound and safe approach to a challenge based on formalised techniques related to the manufacture of Pharmaceutical and medicinal products. |
| B2 | Use information and data from various sources to ensure appropriate informed methodologies and practices are applied when providing solutions to unfamiliar problems. |
| B3 | Recognise the contributions of production, engineering, quality and validation to the range of processes used in the manufacture of pharmaceutical and medicinal products. |
| C1 | Choose appropriate techniques and procedures, and the adoption of best practice, to solve problems |
| C2 | Operate under the regulations governing the Pharmaceutical and Medical Product Manufacturing industry. |
| C3 | Employ techniques and processess, including codes of practice and regulatory frameworks essential for a employee in the Pharmaceutical and Medical Product Manufacturing industry aspiring to higher roles. |
Course Structure
Level 4 Modules
| Module Code | Module Id | Module Title | Module Status | Credit Value | Module Type |
|---|---|---|---|---|---|
| PH1S082 | MOD012502 | Fundamentals of Pharmaceutical Manufacturing Technologies | Running | 20 | specified |
| PH1S083 | MOD012503 | Pharmaceutical Facility Design | Running | 20 | specified |
| PH1S084 | MOD012504 | Fundamentals of Chemistry for the Pharmaceutical Industry | Running | 20 | specified |
Teaching and Assessment
Learning and Teaching Methods
Employer Engagement
Work Placements All adult learners enrolled on the course will already have employment history in either the pharmaceutical and medicinal product manufacturing industry or a related field.
Work-based (i.e., industry led/focussed) Learning All adult learners enrolled on the course will already have employment history in either the pharmaceutical and medicinal product manufacturing industry or a related field and be able to bring that knowledge/experience to help inform their studies.
Other One of the most significant drivers for these experienced working adult learners to undertake these awards is the desire to change or progress their career. All learners engage with the Advanced Career Coaching module when undertaking the University Certificate. Through this module these adult learners are exposed to the wider Pharma community and gain a better understanding of the industry through readings, research and assignment submissions. In addition to the basics of writing a good CV, this module focuses on giving these experienced workers a broad understanding of key information about making a mid-career change into the BioPharmaceutical/Med Tech industry including:
1. Where the companies are located across the country (and in particular which ones are within a 45-minute commute of where they live),
2. Which medicines the companies make and which companies are currently hiring people (GetReskilled host a UK Jobs Board which is updated every 2-weeks),
3. What are the different job roles in a BioPharmaceutical/Med Tech company and what their day-to-day work tasks will involve
The learning outcomes for this module help these experienced workers to engage in an informed discussion about the BioPharmaceutical/Med Tech industry in general (and the company they are applying to in particular) during a job interview. To do this GetReskilled have developed a series of short videos and articles which can be used for extracurricular reading during this module. Likewise, when they are hired they will have the necessary framework to stay abreast of what's happening in the industry going forward. Essentially, they get everything that experienced employees in the BioPharmaceutical/Med Tech industry would have loved to have had back on day-1 when they were starting their career.
GetReskilled have a dedicated Job Hunting Advice Centre which covers detailed steps on how to find a job in the BioPharmaceutical/Med Tech industry, where the BioPharmaceutical/Med Tech companies are located in the UK, detailed job descriptions and salary overviews as well as CV and Interview Advice
https://www.getreskilled.com/pharmaceutical-jobs/job-search/uk/
GetReskilled have a dedicated BioPharmaceutical/Med Tech Jobs Board for the UK which compiles all the current job vacancies in the UK. This is updated every two weeks and sent to the students
https://www.getreskilled.com/pharmaceutical-jobs/uk/
GetReskilled provide detailed advice on how not to just get an initial job, but also how to build a career.
https://www.getreskilled.com/career-planning-for-the-pharma-industry/
While undertaking this module as part of the University Certificate short award, these adult learners will have set up the processes and systems to enable them to continue to develop these skills/an industry awareness while undertaking the next two awards in this integrated package. They will also retain access to the module and the GetReskilled job boards and employment support resources during their further studies.
Below are some of the testimonials GetReskilled has received from adult learners who completed this skills module over the last two years:
\\\"When I started this module, I thought I knew something about job-hunting, but after completing this module I realised I really didn't know anything.\\\"
\\\"This module is amazing! I never realised how many mistakes I made before as regards job-hunting. I feel so much more confident now that I have completed this course, and the process will stay with me forever.\\\"
\\\"At first, I thought this would not be something important to me… but now I see it is even more important than technical skills.
\\\"When I first began this module, I was sceptical, because I thought my CV and cover letter were good enough and I felt it was just the lack of experience as the reason why I wasn't securing employment in the pharmaceutical industry. Now that I have completed this, I can see how wrong I was.\\\"
Means of Assessment
Learning Support
Personal Academic Coach The two short awards do not fall under the requirements for PAC, however, under the existing levels of support provided to learners on these courses, students on these awards will be provided with yearly touchpoints (so one touchpoint for every three modules), which is in excess of the number of touchpoints per number of modules provided for a typical undergraduate course at USW (which is two touchpoints per year for 6 x 20 credit modules). Similarly the students who are enrolled on the BSc (Hons) award, with the existing support mechanism in place, again receive academic touchpoints in excess of that provided to a “typical” USW undergraduate, effectively being provided with four touchpoints for their 6 x 20 credit taught modules (2 per year), in effect being double the equivalent for a normal on campus USW undergraduate student. For further information on the support provided by these touchpoints please see Progress Monitoring and Meetings below
Learner Analytics The online delivery mode of this award enables the use of the learner analytics available through the relevant VLE to monitor the engagement levels of students and facilitate support for those learners whose engagement levels are low (see Progress Monitoring and Meetings below).
Office hours Course Coordinators (see Progress Monitoring and Meetings below) are expected to acknowledge all student emails within 48 hours between 9 am and 5.30 pm.
Formative Assessment Throughout their online material the adult learners are directed to engage with self-assessment questions at key points. The self-assessment questions are designed for the learners to demonstrate their knowledge of the subject and how well they have absorbed the new material. They are encouraged to prepare their answers in the question booklet before copying them into the online learning environment. The over-riding purpose of these questions is to allow the learners to consider what they have learned and identify any gaps in their knowledge. Learners are encouraged to revisit the provided learning materials if they encounter difficulties during this process. The learners are also widely encouraged to view their answers to self-assessment questions as sample interview questions, many being based on those typical of the sort of questions the learners will need to confidently answer to get a job in the pharmaceutical industry.
Progress monitoring and meetings Each student is assigned a dedicated Course Coordinator (GetReskilled) who acts as a single point of contact for these working adult learners during their studies (removing the need to navigate and access multiple contacts and facilitating streamlined efficient communication). The course coordinator acts as a liaison between the adult learner and the relevant topic specialists, passing on any queries/responses if needed. The course coordinator for that learner monitors their engagement and progress with the VLE and communicates with the learner if any concerns arise. The course coordinator also undertakes more formalised progress meetings yearly during the two short awards. These progress meeting increase to three times a year for the BSc award.
In detail:
There will be 3 parts to the learner support structure:
1.As these adult learners will be USW students on a USW award, they will have access to all USW Provisions – including their course handbook noting that they are USW students, the USW VLE, Online Advice Zone and the Disability Services etc. An EIA assessment has been completed with an Outcome 1 result (noting that there is no potential for discrimination or adverse impact)
2.Dedicated Course Coordinator – An Adult Learner Centric Approach - Each student is assigned a dedicated Course Coordinator (GetReskilled) who acts as a single point of contact for these working adult learners during their studies (removing the need to navigate and access multiple contacts and facilitating streamlined efficient communication). The course coordinator acts as a liaison between the adult learner and the relevant topic specialists, passing on any queries/responses if needed. The course coordinator for that learner monitors their engagement and progress with the VLE and communicates with the learner if any concerns arise. The course coordinator also undertakes more formalised progress meetings.
This support mirrors that already in place in the existing partnership with TU-Dublin. Based on the numbers in the existing partnership it is anticipated that the current proposed staffing level/resources will be sufficient to meet the projected increase in student numbers for the proposed USW partnership.
3.Skills Modules – Advanced Career Coaching and Advanced Writing skills
Advanced Career Coaching, provided during the University Certificate and is a 5-week course, where HR specialists guide these adult learners along the complex path of getting a job in this high-tech, highly regulated manufacturing sector, the purpose of which is to ensure that the adult learners employment prospects from the programme are maximized. This online support module has been designed to help experienced workers to help themselves to find employment through a multi-stage process of defining their expectations, setting their goals, visiting on-line job sites, making job applications, networking skills and resource leveraging to find their way into a new career. 82% of adult learners surveyed after completing this module, agree that advanced career coaching significantly benefited them
Advanced Writing Skills is specifically designed to guide these adult learners through a step-by-step process to improve their written communication skills in the workplace. The module provides advice, tools, and tips for successful written communication at work and in academia.
Online Resources Module booklets, notices and announcements, teaching materials and assessment materials are made available on-line through the virtual learning environment. The course is designed such that all necessary supporting material is made available online.
In addition, each module cohort is provided with access to the GetReskilled Community Forum https://community.getreskilled.com/ which provides invaluable Peer online support among these adult learners
Learner wishing to read more around their course can also access textbooks and other reading materials electronically via the USW LRC, however no additional LRC resources are required to support their directed study.
Advice Zone USW operates an Advice Zone that is accessible online https://advice.southwales.ac.uk/advice-zone-online/.
Disability Students can engage with the DS Service at USW that can agree an Individual Support Plan. The plan summarises the support that has been agreed.
IT/Library Students will have access to the LRC which provides access to textbooks, journals, on-line materials and equipment. There are open-access computer laboratories in the Library.
Course Exit Points
| Award | Criteria | Final |
|---|---|---|
| University Certificate | Final |
Progression Route
The following progression routes are available:Successful completion of the University Certificate in Pharmaceutical and Medicinal Product Manufacturing will allow progression onto the University Higher Certificate in Pharmaceutical and Medicinal Product Manufacturing.Successful completion of the University Higher Certificate in Pharmaceutical and Medicinal Product Manufacturing will allow progression onto the BSc in Pharmaceutical and Medicinal Product Manufacturing.Upon completion of the suite of awards, it is expected that most of the adult learners will use their acquired skills and body of evidence accumulated while studying to apply for roles that allow career progression within their existing fields or use it to enter the pharmaceutical and medicinal product manufacturing sector.Completion to level of the BSc Top Up will also enable students to go on to study the MSc in Pharmaceutical Chemistry.
Entry Requirements
Admission to the course is typically through the following qualifications:
University Certificate of Pharmaceutical and Medicinal Product Manufacturing
The admission requirements for the course are as follows:
1. The equivalent of a Level 3 qualification or above
OR
2. The equivalent of a Level 2 qualification (minimum 3 GCSEs including Mathematics and English at Grade C/Grade 4 or above,) AND a recent relevant industry Foundation course
OR
3. Applicants who can demonstrate they have reached Level 2 experiential learning. Although not meeting (1) or (2) above these candidates may be assessed for Exceptional Entry at interview in consultation with the Academic Subject Manager and Head of School.
Inclusive Curriculum Statement
The University of South Wales operates a policy of inclusive learning, teaching and assessment to ensure that all students have an equal opportunity to fulfil their educational potential. Course teams will have considered ways of designing out any potentially disadvantageous element of courses during the course design process. However some specific needs may remain, details about how to apply to have your needs assessed can be found at: http://unilife.southwales.ac.uk/pages/3040-disability-and-dyslexia-service/
Addendum for Delivery at a Partner Institution
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Methods Of Quality Standards
N/A
Quality Of Standards Indicators
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