FBP40522 Certificate IV in Pharmaceutical Manufacturing
CRICOS Course Code: 110369G
COURSE DESCRIPTION
FBP40522 Certificate IV in Pharmaceutical Manufacturing reflects the skills and knowledge for team leaders, supervisors and specialist technical roles within pharmaceutical manufacturing environments. The qualification includes technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of pharmaceutical manufacturing systems, processes and team members.
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 FBP40522 Certificate IV 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 FBP40522 Certificate IV 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
- Pathway requirement integrated as entry requirement as stated below:
Pivotal Education requires international students to complete FBP30822 Certificate III in Pharmaceutical Manufacturing as a relevant entry pathway qualification:
While this pathway requirement is not an entry requirement of the Training Package, students must have competent pharmaceutical manufacturing operational skills in order to develop technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of systems, processes and team members required at the Certificate IV level.
DURATION
FBP40522 Certificate IV in Pharmaceutical Manufacturing has been packaged with FBP30822 Certificate III in Pharmaceutical Manufacturing for overseas students and as such, credit transfer is granted for the following units of competency that are included in both qualifications:
- FBPPHM3004 Clean and sanitise facilities and equipment
- FBPPPL3006 Report on workplace performance
Therefore, the total duration for FBP40522 Certificate IV in Pharmaceutical Manufacturing after granting credit transfer for the stated units of competency above is 40 weeks as follows:
- 30 weeks delivery and assessment (3 x 10-week terms)
- 10 weeks term break
EMPLOYMENT OUTCOMES
Graduates of this qualification may apply for a role such as a Pharmaceutical Production Supervisor.
PATHWAYS
After successfully achieving FBP40522 Certificate IV in Pharmaceutical Manufacturing, candidates may develop their pathway to relevant further studies in pharmaceutical manufacturing at the Diploma or higher-level qualification.
QUALIFICATION STRUCTURE AND CONTENT
FBP40522 Certificate IV in Pharmaceutical Manufacturing consists of sixteen (16) units of competency:
- 8 core units, plus
- 8 elective units
| Unit Code | Unit Title | C/E |
| BSBLDR414 | Lead team effectiveness | Core |
| BSBWHS411 | Implement and monitor WHS policies, procedures and programs | Core |
| FBPPHM4001 | Monitor and maintain good manufacturing practice requirements | Core |
| FBPPHM4002 | Prepare and review workplace documentation to support good manufacturing practice requirements | Core |
| FBPPHM4003 | Facilitate contamination control | Core |
| FBPPHM4005 | Participate in validation of pharmaceutical manufacturing processes | Core |
| FBPPHM4006 | Respond to non-conformance | Core |
| FBPPPL3006 | Report on workplace performance | Core |
| FBPPPL4002 | Plan and coordinate production equipment maintenance | Elective |
| FBPTEC4007 | Describe and analyse data using mathematical principles | Elective |
| FBPTEC4011 | Establish process capability. | Elective |
| FBPPHM3004 | Clean and sanitise facilities and equipment | Elective |
| MSS402080 | Undertake root cause analysis | Elective |
| BSBLDR411 | Demonstrate leadership in the workplace | Elective |
| BSBOPS402 | Coordinate Business operational plan | Elective |
| BSSTR402 | Implement continuous improvement | 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 MODE
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 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 FBP40522 Certificate IV 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.
