FBP30821 Certificate III in Pharmaceutical Manufacturing

CRICOS Course Code: 108926A

COURSE DESCRIPTION

FBP30821 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 FBP30821 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 FBP30821 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 FBP30821 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 FBP30821 Certificate III in Pharmaceutical Manufacturing, candidates may undertake FBP40318 Certificate IV in Pharmaceutical Manufacturing

QUALIFICATION STRUCTURE AND CONTENT

FBP30821 Certificate III in Pharmaceutical Manufacturing consists of sixteen (16) units of competency:

  • 5 core units, plus
  • 11 elective units

Unit CodeUnit Title C/E
BSBWHS311Assist with maintaining workplace safetyCore
FBPPHM3001Apply Good Manufacturing Practice requirementsCore
FBPPHM3002Operate a pharmaceutical production processCore
FBPPHM3003Work in a controlled environmentCore
FBPPHM3004Clean and sanitise facilities and equipmentCore
FBPOPR2028Operate a mixing or blending processElective
FBPOPR3005Operate interrelated processes in a production systemElective
FBPOPR3006Operate interrelated processes in a packaging systemElective
FBPPHM3011Dispense pharmaceutical raw materialsElective
FBPPHM3018Operate a sterilisation process using an autoclaveElective
FBPOPR2070Apply quality systems and proceduresElective
FBPOPR3004Set up a production or packaging line for operationElective
FBPPPL3003Participate in improvement processesElective
FBPPPL3006Report on workplace performanceElective
MSMENV272Participate in environmentally sustainable work practicesElective
MSS403085Ensure process improvements are sustainedElective

DELIVERY LOCATIONS

Pivotal Education delivers in the following locations:

Mode of DeliveryLocationFacilities & Equipment
Theory Based – classroom84 – 86 Mary Street, Surrey Hills NSW 2010  Full campus facilities: classrooms internet access white boards student common room library access self-study areas student amenities
Practical Application – simulated industry environmentBiologics 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
  • Online Learning – Students must complete online learning every week using Canvas 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. Online 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 online learning via Canvas

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

The City of Sydney Library Services branches are located at the following:

  • Customs House Library
  • Glebe Library
  • Green Square Library
  • Haymarket Library
  • Kings Cross Library
  • Newtown Library
  • Pyrmont Link
  • Surrey Hills Library
  • Library Express
  • Ultimo Library
  • Waterloo Library

The conditions of membership are as follows:

  • Membership is free to all residents of New South Wales
  • Students must agree to abide by all City of Sydney Library Service policies and conditions of use and:
    • Accept responsibility for all items borrowed on the library card
    • Pay replacement costs plus processing charges for any items lost, stolen or damaged
  • Students must report lost/stolen cards to the City of Sydney Library Service immediately
  • Return borrowed items on or before the due date or check whether the item can be renewed
  • Respect the rights and security of staff and other library users
  • Notify the City of Sydney Library Service of any changes to contact details provided
  • Students can find further information by visiting the City of Sydney Library Service website at http://www.cityofsydney.nsw.gov.au/library/Default.asp

EXIT POINT/AWARD

Students that successfully complete all 16 units of competency as stated in the Course Structure will be issued with FBP30821 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