FDF30210 Certificate III in Pharmaceutical Manufacturing. Certificate III in Pharmaceutical Manufacturing InfoPack V1.

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1 FDF30210 Certificate III in Pharmaceutical Manufacturing Certificate III in Pharmaceutical Manufacturing InfoPack V P age

2 Certificate III in Pharmaceutical Manufacturing The HS Business School Certificate III in Pharmaceutical Manufacturing is a comprehensive course and targets people who currently work or will work as operators in the pharmaceutical, biotechnology or complementary medicines industries. The Certificate III in Pharmaceutical Manufacturing is for those people requiring team leader and higher production skills for pharmaceutical manufacturing environments. It builds upon industry specific skills and knowledge and allows greater emphasis on leadership, problem solving as well as increased technical ability. Prerequisite Requirements The Certificate III in Pharmaceutical Manufacturing qualification does not specify entry requirements for this course, however, it will be difficult for candidates without relevant vocational training and/or work experience to acquire the skills required to complete the qualification. It is preferable that candidates have completed year 10 of schooling and are computer literate with good verbal, writing and numeracy skills. Successful completion of the Certificate III in Pharmaceutical Manufacturing allows you to work in such positions as compounder, production team- leader, packaging team- leader, dispenser or tablet/capsule maker. When you enrol into the Certificate III in Pharmaceutical Manufacturing course with HS Business School, your login details will be sent to you and you will be able to access all of your training material via online download. There is no need to wait for classes to start or for the next intake. Our Certificate III in Pharmaceutical Manufacturing training materials include Participant Learning Guides, assessment tools for each unit of competence and research materials. We find that this is a great way to save time and get through your qualification quickly and easily. Our Certificate III in Pharmaceutical Manufacturing course is delivered over a period of 20 days of workshop/classroom activities in 4 separate sessions of one 5 day week duration, notionally two months apart. Each session is followed by self- directed activities to complete assessment and project tasks. Each workshop is followed by self- directed activities to complete the assessment tasks. Face- to- face training and assessment is typically delivered in a classroom setting and will simulate the premises of a business when required. Because processes may vary between manufacturing facilities, where the client has suitable premises, training will preferably be conducted at their premises. Whilst the course is delivered during four 5 day workshops, you will be given 12 months to complete all of the assessments. Certificate III in Pharmaceutical Manufacturing InfoPack V P age

3 Why study with HS Business School? We are results orientated Participants who take part in our specially designed programs are guided to carry out significant workplace projects that demonstrate actual performance improvements. We are specialists We are specialists in management development and workplace health and safety. We have a great deal of experience in working with clients in Australia and overseas. We continually research the latest pharmaceutical management methodologies and incorporate them into our programs. Quality learning materials We pride ourselves in providing you with quality learning materials. In our courses we combine the benefits of online downloadable electronic resources to enable you to complete your studies at your own pace in your own environment. For work undertaken outside the workshop environment you will be allocated an assessor who can be contacted by telephone, Skype and/or in order to discuss assessment solutions or any other matter that concerns your learning and assessment activities. We employ state- of- the art online learning resources for our Certificate III in Pharmaceutical Manufacturing, developed by experienced industry professionals and augmented by our own targeted training resources. Certificate III in Pharmaceutical Manufacturing InfoPack V P age

4 FDF30210 Certificate III in Pharmaceutical Manufacturing Course Structure To be awarded the FDF30210 Certificate III in Pharmaceutical Manufacturing, participants must successfully complete a total of sixteen units of study. The FDF30210 Certificate III in Pharmaceutical Manufacturing will be delivered and assessed as clusters of units when outcomes clearly support integrated assessment and stand- alone units where there are no overlapping outcomes. The following clusters of units are deemed appropriate for the delivery of this qualification: 1. Processes 2. GMP and Quality 3. Workplace Health & Safety 4. Leadership and Training The units in each cluster are identified in the table below: Core Units: FDFOHS3001A Contribute to OHS processes C FDFOP2064A Provide and apply workplace information C FDFPH3001A Monitor and maintain Good Manufacturing Practice procedures C MSAENV272B Participate in environmentally sustainable work practices C Elective Units: Group A FDFOP3003A Operate inter- related processes in a production system E FDFOP3004A Operate inter- related processes in a packaging system E Elective Units: Group B FDFPPL3001A Participate in improvement processes E FDFPPL3003A Support and mentor individuals and groups E FDFPPL3005A Participate in an audit process E FDFOP3002A Set up a production or packaging line for operation E MEM13003B Work safely with industrial chemicals and materials E MSACMC411A Lead a competitive manufacturing team E MSACMC413A Lead team culture improvement E Certificate III in Pharmaceutical Manufacturing InfoPack V P age

5 FDFOP2061A Use numerical applications in the workplace E MSL973001A Perform basic tests E Elective Units: Group C MSACMT240A Apply 5S procedures in a manufacturing environment E TAEDEL301A Provide work skill instruction E TAEASS402B Assess competence E TAEASS403B Participate in assessment validation E TAEASS401B Plan assessment activities and processes E HLTFA301B Apply first aid E Units packaged at Group A in FDF20210 Certificate II in Pharmaceutical Manufacturing FDFPH2005A - Operate an aseptic fill and seal process E FDFPH2006A - Operate an aseptic form, fill and seal process E FDFPH2007A - Coordinate a label store E FDFPH2008A - Operate a compressing process E FDFPH2009A - Dispense pharmaceutical raw materials E FDFPH2010A - Operate an encapsulation process E FDFPH2011A - Operate a granulation process E FDFPH2012A - Operate a liquid manufacturing process E FDFPH2013A - Operate a tablet coating process E FDFPH2014A - Operate a terminal sterilisation process E C = Core Units. E = Elective Units offered. Pathways from the Qualification After achieving the FDF30210 Certificate III in Pharmaceutical Manufacturing, you may undertake the FDF40210 Certificate IV in Pharmaceutical Manufacturing, a qualification for those wishing to develop specialised skills and knowledge required to coordinate and maintain the GMP programs within an organisation. Certificate III in Pharmaceutical Manufacturing InfoPack V P age

6 Assemble Materials Dispense Materials Granulabon Blend Compression Coabng Indicative Curriculum: Pharmaceutical Process Worker Team Leader Tablet Department Certificate III in Pharmaceutical Manufacturing (FDF30210) 16 Units Process Flow Process Units GMP & WHS Units Training & Leadership Units Requisibon Move to Dispensary Weigh Transfer Materials Mix Dry Mill Add Excipients Blend Discharge Compress Tablets Move to Coabng Coat Tablets Move to Packaging MSAENV272B Participate in environmentally sustainable work practices FDFOP3003A Operate inter- related processes in a production system FDFPH2009A Dispense pharmaceutical raw materials FDFPH2011A Operate a granulation process FDFPH2008A Operate a compressing process FDFPH2013A Operate a tablet coating process GMP Units FDFOP2064A Provide and apply workplace information FDFPH3001A Monitor and maintain Good Manufacturing Practice procedures FDFPPL3005A Participate in an audit process FDFOP2061A Use numerical applications in the workplace WHS Units FDFOHS3001A Contribute to OHS processes MEM13003B Work safely with industrial chemicals and materials Suggested Additional Unit: HLTFA301B Apply first aid Enterprise Trainer & Assessor Skillset TAEDEL301A Provide work skill instruction TAEASS401B Plan assessment activities and processes TAEASS402B Assess competence TAEASS403B Participate in assessment validation Alternative Leadership Units FDFPPL3003A Support and mentor individuals and groups MSACMC411A Lead a competitive manufacturing team MSACMC413ALead team culture improvement MSACMT240A Apply 5S procedures in a manufacturing environment Certificate III in Pharmaceutical Manufacturing InfoPack V P age

7 FREQUENTLY ASKED QUESTIONS Q1. How is the course delivered? Downloadable delivery of training resources: you will get access to your course material for 12 months and can start working on the course immediately. Q2. Do I get my course materials in a hard copy? No. The material is available online. However, there is a Print version for each unit in PDF format, which you can download, save and print if you prefer to read it off line. Q3. How long will it take me to complete the course? Our courses are self- paced and you will have 12 months from your enrolment date to complete your qualification. To complete the course within 12 months it is recommended that 8 to 10 hours per week be scheduled for study and assignments. Students can self- assess their pace by setting a target of completing two units per month. Q4. How will I be assessed for competency? There are various assessment requirements throughout the course dependent upon the context of each unit. In most cases you will be required to submit assignments that demonstrate your knowledge and competency. The assignments may consist of essays and question and answers or they may require you to complete workplace projects. If you are ever unsure of the volume of work with your essays or projects, simply send what you have done to your trainer. The trainer will provide guidance if more is required. Q5. I have completed some pharmaceutical manufacturing courses in the past/have experience working as an operator/manager; can I seek Recognition of Prior Learning (RPL)? Yes you can apply for RPL. Simply ask your enrolment coordinator for the Student RPL Package. The Student RPL Package is designed to take you step- by- step through the requirements for applying for RPL. Q6. What is HS Business School s refund policy? Students are entitled to a full refund if HS Business School cancels a course or fails to make training materials available within a reasonable timeframe. Refunds will not be given for any of the following reasons: Failure to attend a scheduled training session Non- completion of assessment activities Change of mind about a course, or, Other circumstances beyond our control. No refund will be given if a student has been enrolled in an online or distance course for more than one (1) month. Q7. Where can I access HS Business School s Policies and Procedures? Our policies and procedures including RPL (recognition of prior learning), appeals and service delivery standards can be found in the Participant Handbook which is available via the Links on our website Certificate III in Pharmaceutical Manufacturing InfoPack V P age

8 HS Business School is a leader in career advancement training courses. Our students have access to highly experienced, passionate trainers, who are there to guide them through the course and ensure they are successful in their chosen field of study. Contact: mbk@hs.edu.au PO Box 696, Avalon Beach, NSW, 2107 Australia Phone: info@hs.edu.au PO Box 957N, North Cairns, Qld 4870 Australia Phone: Fax: RTO Certificate III in Pharmaceutical Manufacturing InfoPack V Page