FBP30822 Certificate III in Pharmaceutical Manufacturing
CRICOS Course Code: 110407F
COURSE DESCRIPTION
FBP30822 Certificate III in Pharmaceutical Manufacturing describes the skills and knowledge for production and packaging roles carried out under broad supervision within pharmaceutical manufacturing environments. Individuals with this qualification perform tasks involving a broad range of skills that are applied in a wide variety of contexts, which will involve discretion and judgement in selecting and operating equipment, coordinating resources and applying contingency measures during work.
Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.
ENTRY REQUIREMENTS
Although there are no stated entry requirements for FBP30822 Certificate III in Pharmaceutical Manufacturing in the FBP Training Package, international students must be 18 years of age and above, and provide evidence of the published entry requirements as stated below:
Pivotal Education specific course entry requirements for FBP30822 Certificate III in Pharmaceutical Manufacturing for international students are as follows:
- Academic
- Australian Year 12 or equivalent of Australian HSC;
- English Language
- IELTS 5.5 band overall or equivalent (with no band less than 5.0) or equivalent
OR
Any relevant AQF qualification at the Certificate III level or above delivered and assessed in English only will be deemed as meeting both the academic and English language entry requirements.
DURATION
The total duration for FBP30822 Certificate III in Pharmaceutical Manufacturing is 76 weeks:
- 60 weeks (6 x 10-week terms)
- 16 weeks term break
EMPLOYMENT OUTCOMES
Graduates of this qualification may apply for a role such as a Pharmaceutical Production Leading Hand.
PATHWAYS
After successfully achieving FBP30822 Certificate III in Pharmaceutical Manufacturing, candidates may undertake FBP40522 Certificate IV in Pharmaceutical Manufacturing.
QUALIFICATION STRUCTURE AND CONTENT
FBP30822 Certificate III in Pharmaceutical Manufacturing consists of sixteen (16) units of competency:
- 5 core units, plus
- 11 elective units
| Unit Code | Unit Title | C/E |
| BSBWHS311 | Assist with maintaining workplace safety | Core |
| FBPPHM3003 | Work in a controlled environment | Core |
| FBPPHM3004 | Clean and sanitise facilities and equipment | Core |
| FBPPHM3020 | Apply good Manufacturing Practice requirements | Core |
| FBPPHM3021 | Operate a pharmaceutical production process | Core |
| FBPOPR2082 | Operate a mixing or blending process | Elective |
| FBPOPR3019 | Operate and monitor interrelated processes in a production or packaging system | Elective |
| FBPPHM3008 | Operate an aseptic form, fill and seal process | Elective |
| FBPPHM3011 | Dispense pharmaceutical raw materials | Elective |
| FBPPHM3018 | Operate a sterilisation process using an autoclave | Elective |
| FBPOPR2070 | Apply quality systems and procedures | Elective |
| FBPOPR3004 | Set up a production or packaging line for operation | Elective |
| FBPPPL3003 | Participate in improvement processes | Elective |
| FBPPPL3006 | Report on workplace performance | Elective |
| MSS403085 | Ensure process improvements are sustained | Elective |
| MSMENV272 | Participate in environmentally sustainable work practices | Elective |
DELIVERY LOCATIONS
Pivotal Education delivers in the following locations:
| Mode of Delivery | Location | Facilities & Equipment |
| Theory Based – classroom | 84 – 86 Mary Street, Surry Hills NSW 2010 | Full campus facilities: – classrooms – internet access – student common room – library access – self-study areas |
| Practical Application – simulated industry environment | Biologics Innovation Facility Level 0, UTS Vicki Sara Building (Building 7) 67 Thomas St Broadway, NSW 2007 University of Technology Australia | The UTS Biologics Innovation Facility (BIF) is an unmatched GMP bioprocessing teaching and training facility, designed to drive opportunities to up-skill and scale-up biopharmaceutical projects using state of the art single-use equipment and industry’s best practice processing techniques. |
DELIVERY STRUCTURE
Students study full time mixed mode of delivery that integrates:
- Classroom based training sessions to develop the knowledge and theoretical understandings required to undertake work within the food industry. Classroom settings ensure full access to internet, whiteboards and campus facilities. Attendance in classroom-based training sessions is mandatory and students who do not attend are not eligible to undertake practical training and assessment
- Practical training is delivered and assessed in the BIF Facility University of Technology which is a fully simulated industry environment allowing for practical training and assessment to occur in a simulated environment. During the practical sessions, enough time is allocated to students to prepare, practice their skills, reinforce their knowledge and prepare themselves for the practical assessments. Attendance in practical training and experience is mandatory and students who do not attend are not eligible to undertake assessment
- Blended learning – Students must complete blended part of learning every week using Moodle to complete research, knowledge preparation and formative assessment activities including associated review questions to enhance their understanding. This time is included in the scheduled hours of training per week. Blended learning is monitored and recorded to comply with Standard 8 National Code of Practice 2018
- Self-study for class reading, assessment research, preparation and completion – In addition, successful completion of this course will require students to engage in the following self-study time that is essential to be undertaken in the student’s own time outside the scheduled 20 hours per week to include but not limited to:
- Read the relevant chapters in their learning materials prior to class so that the theory presentation has some context and meaning as students will better understand the theory presentation
- Answer the questions at the end of the relevant chapter prior to attending class so that the trainer can run through with the class integrated with the theory presentation
- Research, preparation and completion of summative written assessment tasks
- Practical assessment preparation
- Any other additional reading and exploration of suggested resources
ASSESSMENTS REQUIREMENTS
Students will be assessed using relevant assessment methods for each unit which includes but is not limited to the following:
- Knowledge questions
- Verbal questions
- Projects
- Portfolios
- Practical demonstrations
- Presentations
At the beginning of each unit of competency, students are provided with information for that unit of competency that clearly outlines the assessment tasks required including the criteria and due dates. Students that require reassessment will be required to pay a reassessment fee as published in the Schedule of Fees and Charges.
TIMETABLE
Students are required to undertake 20 scheduled hours per week during term time as follows:
- 15 x hours per week face to face classes
- 5 x hours per week integrated blended part of learning via Moodle
Students are allocated to scheduled classes based on class numbers and availability. Pivotal Education reserves the right to change the timetable where required.
MATERIALS, RESOURCES AND LIBRARY ACCESS
Pivotal Education students are provided with resources on commencement of their course. This includes student learning and assessment resources accessed via Canvas and any required PPE equipment and consumables for practical training and assessment.
Pivotal Education students can also complete the online application to join the City of Sydney Library Service through the online website access at
https://library.cityofsydney.nsw.gov.au/Montage/Join.aspx
EXIT POINT/AWARD
Students that successfully complete all 16 units of competency as stated in the Course Structure will be issued with FBP30822 Certificate III in Pharmaceutical Manufacturing by Pivotal Education. This qualification is recognised nationally under the Australian Qualifications Framework (AQF).
Students that complete some but not all of the units of competency as stated in the Course Structure may be issued with a Statement of Attainment by Pivotal Education. It will identify only those units of competence that have been completed as part of the qualification and recognised nationally under the AQF.
