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Qualification details

FDF50210 - Diploma of Pharmaceutical Manufacturing (Release 1)

Summary

Usage recommendation:
Deleted
The Deleted usage recommendation was implemented on 13 June 2017 to describe training components that have no replacement. Enrolments in training components and statements of attainment or qualifications issued before 13 June 2017 are valid. For any components marked as deleted after 13 June 2017, the applicable transition/teach-out periods apply. For specific questions regarding the enrolment, delivery or issuance of a statement of attainment/qualification, please contact your training regulator.
Mapping:
MappingNotesDate
DeletedDeleted from FDF10 Food Processing17/Dec/2018
Supersedes FDF50207 - Diploma of Pharmaceutical Manufacturing30/Jan/2011

Releases:
ReleaseRelease date
(View details for release 3) 06/Sep/2012
(View details for release 2) 04/Nov/2011
1 (this release) 31/Jan/2011

Delivery:
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Training packages that include this qualification

Replaced release

You are currently viewing the components related to release 1.
The current release is release 3.  View release 3 details.

Units of competency

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MSACMT280A - Undertake root cause analysisUndertake root cause analysisSupersededN/A
BSBFIM501A - Manage budgets and financial plansManage budgets and financial plansSupersededN/A
BSBWOR502A - Ensure team effectivenessEnsure team effectivenessSupersededN/A
FDFPPL4001A - Manage people in the work areaManage people in the work areaSupersededN/A
MSACMC610A - Manage relationships with non-customer external organisationsManage relationships with non-customer external organisationsSupersededN/A
FDFPH4006A - Respond to non-conformanceRespond to non-conformanceSupersededN/A
MSACMT623A - Develop a levelled pull system of manufacturingDevelop a levelled pull system of manufacturingSupersededN/A
FDFPH4002A - Facilitate and monitor Good Manufacturing PracticeFacilitate and monitor Good Manufacturing PracticeDeletedN/A
MSACMT230A - Apply cost factors to work practicesApply cost factors to work practicesSupersededN/A
BSBMGT515A - Manage operational planManage operational planSupersededN/A
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Classifications

SchemeCodeClassification value
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 421 Diploma 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Manager 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 02/Sep/2011 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 02/Sep/2011 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 02/Sep/2011 
Qualification/Course Level of Education Identifier 421 Diploma 31/Jan/2011 
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Modification History

Not applicable.

Description

This qualification covers the pharmaceutical manufacturing specialisation.

Job Roles  The Diploma of Pharmaceutical Manufacturing targets those in senior management, technician or similar roles within pharmaceutical manufacturing industries. It provides extensive skills and knowledge of industry management functions and environment, and the ability to take responsibility for workplace systems.

Pathways  into the qualification  Pathways for candidates considering this qualification include:

  • FDF40210 Certificate IV in Pharmaceutical Manufacturing
  • direct entry
  • relevant vocational training and/or work experience.

Pathways  from the qualification  After achieving this qualification, candidates may undertake a relevant Advanced Diploma qualification.

Additional qualification advice 

Units selected from other Training Packages must be relevant to the work outcome, local industry requirements and the qualification level.

Note: AgriFood Skills Australia expects that the design of any training delivery and assessment program to support the achievement of this qualification is based on:

  • the context required by the industry and/or enterprise
  • a holistic and integrated training delivery and assessment plan that identifies learning activities and evidence required
  • flexible delivery options including on-the-job and work-based training that support the development of competency.

Pathways Information

Not applicable.

Licensing/Regulatory Information

Licensing , Legislative , Regulatory or Certification Considerations  There is no direct link between this qualification and licensing, legislative and/or regulatory requirements. However, an individual unit of competency may specify relevant licensing, legislative and/or regulatory requirements. In addition, all work must comply with Good Manufacturing Practice, occupational health and safety (OHS) and environmental regulations and legislation that apply to the workplace.

Entry Requirements

Not applicable.

Employability Skills Summary

EMPLOYABILITY SKILLS QUALIFICATION SUMMARY 

Diploma of Pharmaceutical Manufacturing 

The following table contains a summary of the Employability Skills as identified by the pharmaceutical manufacturing related industries for this qualification. This table should be interpreted in conjunction with the detailed requirements of each unit of competency packaged in this qualification. The outcomes described here are broad industry requirements that reflect skill requirements for this level.

Employability Skill 

Industry /enterprise requirements for this qualification include :

Communication
  • Complete a range of workplace documentation and records
  • Select communication technologies to support work operations
  • Develop work instructions, specifications and procedures
  • Demonstrate effective and appropriate communication and interpersonal skills when dealing with people
  • Communicate with all people at all levels of the organisation in a professional manner
  • Select and apply documentation, communication and interpersonal strategies when dealing with internal and external clients
  • Select communication methods according to priority, cost and audience needs
  • Analyse and apply technical information
  • Analyse data and information to determine implications for work operations

Teamwork
  • Lead cooperative work relations with people of different ages, gender, race or religion
  • Provide leadership
  • Determine performance required to meet internal and external customer needs
  • Manage organisational processes and provide problem solving support to others
  • Facilitate team achievements

Problem-solving
  • Investigate problem causes and implement corrective strategies
  • Identify and address potential and actual problems associated with work operations or in achieving work outcomes
  • Identify environmental features, regulations, insurance requirements, legal requirements and other factors which may affect the product or service to be provided
  • Use material and process knowledge to solve problems
  • Identify hazards and suggest control measures
  • Analyse food safety practices

Initiative and enterprise
  • Determine information gathering requirements to monitor work processes and procedures
  • Determine quality and other indicators of work
  • Identify efficient production processes
  • Determine and act on situations requiring further information or problem solving
  • Implement continuous improvement processes
  • Provide leadership in the workplace
  • Implement business development processes

Planning and organising
  • Identify hazards and implement appropriate hazard control measures
  • Demonstrate time management skills
  • Determine resource requirements
  • Determine work timelines and output targets
  • Optimise work processes
  • Conduct business planning processes

Self-management
  • Analyse implications of relevant acts and regulations on work practices
  • Monitor work operations and identify and act on any quality and performance issues
  • Manage own time to meet deadlines
  • Determine workplace procedures and instructions
  • Conduct work reviews to determine improvement requirements

Learning
  • Develop learning opportunities
  • Be supportive, assertive and use interpersonal skills to encourage workplace learning
  • Identify own training needs and seek skill development if required
  • Gather feedback to own work to assess effectiveness in meeting objectives and integrate information into own practice
  • Assess work data and information to identify areas for improved performance
  • Maintain currency of industry skill and knowledge

Technology
  • Select computer software applications to perform work operations
  • Work with technology safely and according to workplace standards
  • Help others use technology efficiently and safely
  • Ensure readiness and operational efficiency of workplace technology

Packaging Rules

Packaging Rules 

This qualification requires the achievement of twenty nine  (29 ) units of competency in accordance with the following rules.

Total units must include a minimum of eleven  (11 ) units coded FDF .

Nine  (9 ) Core units 

Twenty  (20 ) Elective units 

Elective selection must include :

  • One (1) Group A elective unit
  • One (1) Group B elective unit
  • Six (6) Group C elective units
  • Five (5) Specialist and Cross Sector units packaged at Certificate IV Group C

Seven  (7 ) remaining elective units may be selected from :

  • Group A elective units below, not previously selected
  • Group B elective units below, not previously selected
  • Group C elective units below, not previously selected
  • Group D elective units
  • Units packaged at FDF30210 Certificate III in Pharmaceutical Manufacturing or FDF40210 Certificate IV in Pharmaceutical Manufacturing (maximum of 5)
  • Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 5)
  • A maximum of 4 units from any nationally endorsed Training Package and accredited course that are packaged at Certificate II level (maximum 2 units), Certificate III level (maximum 2 units), Certificate IV level (maximum 3 units), Diploma or Advanced Diploma level (maximum 3 units)

NOTE: Units marked with an asterisk (*) require completion of prerequisite unit/s which is identified under the unit.

CORE UNITS 

Complete the following nine (9) units:

FDFPH4001A

Prepare and review workplace documentation to support GMP

FDFPH4002A

Facilitate and monitor Good Manufacturing Practice

FDFPH4003A

Facilitate contamination control

FDFPH4005A

Participate in validation processes

FDFPH4006A

Respond to non-conformance

FDFPPL3002A

Report on workplace performance

FDFPPL4001A

Manage people in the work area

FDFTEC4007A

Describe and analyse data using mathematical principles

MSAENV472A

Implement and monitor environmentally sustainable work practices

ELECTIVE UNITS 

GROUP A 

Select a minimum of one (1) Group A elective units.

FDFOHS4001A

Identify, assess and control OHS risk in own work

FDFOHS5001A

Manage OHS processes

GROUP B 

Select a minimum of one (1) Group B elective units.

FDFOP3003A

Operate inter-related processes in a production system

FDFOP3004A

Operate inter-related processes in a packaging system

GROUP C 

Select a minimum of six (6) Group C elective units.

FDFPPL4003A

Schedule and manage production

FDFPPL4007A

Manage supplier agreements and contracts

FDFPPL5001A

Design and maintain programs to support legal compliance

FDFTEC5001A

Manage and evaluate new product trials

FDFTEC5002A

Manage utilities and energy for a production process

BSBATSIM507B

Establish and maintain a strategic planning cycle

BSBCOM502B

Evaluate and review compliance

BSBCOM503B

Develop processes for the management of breaches in compliance requirements

BSBMGT502B

Manage people performance

BSBMGT515A

Manage operational plan

BSBMGT516A

Facilitate continuous improvement

BSBPMG510A

Manage projects

MEM15001B

Perform basic statistical quality control

MSACMC611A

Manage people relationships

MSACMS600A

Develop a competitive manufacturing system

MSACMT620A

Develop quick changeover procedures

MSACMT650A

Determine and improve process capability*

MSACMT452A Apply statistics to processes in manufacturing 

MSACMT670A

Develop and manage sustainable energy practices

MSACMT671A

Develop and manage sustainable environmental practices

GROUP D 

BSBCUS501A

Manage quality customer service

BSBFIM501A

Manage budgets and financial plans

BSBMKG501B

Identify and evaluate marketing opportunities

BSBOHS503B

Assist in the design and development of OHS participative arrangements

BSBWOR502A

Ensure team effectiveness

MSACMC410A

Lead change in a manufacturing environment

MSACMC610A

Manage relationships with non-customer external organisations

MSACMC612A

Manage workplace learning

MSACMC613A

Facilitate holistic culture improvement in a manufacturing enterprise

MSACMC614A

Develop a communications strategy to support production

MSACMS601A

Analyse and map a value chain

MSACMS605A

Develop a balanced score card for use in competitive manufacturing*

MSACMS601A Analyse and map a value chain 

MSACMT280A Undertake root cause analysis 

MSACMT631A Undertake value analysis of product costs in terms of customer requirements 

MSACMS606A

Introduce competitive manufacturing to a small or medium enterprise

MSACMT230A

Apply cost factors to work practices

MSACMT280A

Undertake root cause analysis

MSACMT452A

Apply statistics to processes in manufacturing

MSACMT622A

Design a process layout

MSACMT623A

Develop a levelled pull system of manufacturing

MSACMT630A

Optimise cost of product*

MSACMT631A Undertake value analysis of product costs in terms of customer requirements 

MSACMT631A

Undertake value analysis of product costs in terms of customer requirements

MSACMT632A

Analyse cost implications of maintenance strategy

MSACMT640A

Manage 5S system in a manufacturing environment

MSACMT661A

Determine and establish information collection requirements and processes

MSACMT662A

Develop a documentation control strategy for a manufacturing enterprise

MSACMT675A

Facilitate the development of a new product*

MSACMT452 Apply statistics to processes in manufacturing 

MSACMT681A

Develop a proactive maintenance strategy

MSACMT682A

Adapt a proactive maintenance strategy to the process manufacturing sector*

MSACMT681A Develop a proactive maintenance strategy 

MSACMT683A

Adapt a proactive maintenance strategy for a seasonal or cyclical manufacturing operation*

MSACMT681A Develop a proactive maintenance strategy 

MSACMT660A

Develop the application of enterprise systems in manufacturing

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