CHEM ENG 4036 - Pharmaceutical Process Validation & Quality
North Terrace Campus - Semester 2 - 2019
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General Course Information
Course Details
Course Code CHEM ENG 4036 Course Pharmaceutical Process Validation & Quality Coordinating Unit School of Chemical Eng and Advanced Materials(Ina) Term Semester 2 Level Undergraduate Location/s North Terrace Campus Units 3 Contact Up to 4 hours per week Available for Study Abroad and Exchange Y Assessment Assignments, project reports, final examination Course Staff
Course Coordinator: Professor Robert Falconer
Course Timetable
The full timetable of all activities for this course can be accessed from .
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Learning Outcomes
Course Learning Outcomes
On successful completion of this course students will be able to:
1 Explain the regulatory basics for process validation and outline the prospective validation 2 Use the GMP regulation regarding the ultilities n Pharmaceutical manufacturing 3 Apply the validation of sterilization, lyophilisation and solid dosages forms 4 Explain the process of pharmaceutcial packaging and quality control 5 Assess the environmental impact of a industrial process. 6 Demonstrate the process of validation and quality assurance 7 Examine the harmonization, GMPs and validations in global level
The above course learning outcomes are aligned with the Engineers Australia .
The course is designed to develop the following Elements of Competency: 1.1 1.3 1.4 1.5 1.6 2.1 2.2 2.3 2.4 3.1 3.2 3.3 3.4 3.6
University Graduate Attributes
This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:
University Graduate Attribute Course Learning Outcome(s) Deep discipline knowledge
- informed and infused by cutting edge research, scaffolded throughout their program of studies
- acquired from personal interaction with research active educators, from year 1
- accredited or validated against national or international standards (for relevant programs)
1-4 Critical thinking and problem solving
- steeped in research methods and rigor
- based on empirical evidence and the scientific approach to knowledge development
- demonstrated through appropriate and relevant assessment
1-4 Teamwork and communication skills
- developed from, with, and via the SGDE
- honed through assessment and practice throughout the program of studies
- encouraged and valued in all aspects of learning
1-7 Career and leadership readiness
- technology savvy
- professional and, where relevant, fully accredited
- forward thinking and well informed
- tested and validated by work based experiences
1-7 Intercultural and ethical competency
- adept at operating in other cultures
- comfortable with different nationalities and social contexts
- able to determine and contribute to desirable social outcomes
- demonstrated by study abroad or with an understanding of indigenous knowledges
5-7 Self-awareness and emotional intelligence
- a capacity for self-reflection and a willingness to engage in self-appraisal
- open to objective and constructive feedback from supervisors and peers
- able to negotiate difficult social situations, defuse conflict and engage positively in purposeful debate
5-7 -
Learning Resources
Recommended Resources
Reference Books
Robert A. Nash and Alfred H. Wachter, Pharmaceutical Process Validation, Marcel Dekker Inc., New York. Basel. 2003
Michael Levin, Pharmaceutical Process Scale-Up. Taylor & Francis, 2005
Andrew A. Signore, Terry Jacobs, Good Design Practices for GMP Pharmaceutical Facilities, Taylor & Francis, 2005
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Learning & Teaching Activities
Learning & Teaching Modes
No information currently available.
Workload
No information currently available.
Learning Activities Summary
No information currently available.
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Assessment
The University's policy on Assessment for Coursework Programs is based on the following four principles:
- Assessment must encourage and reinforce learning.
- Assessment must enable robust and fair judgements about student performance.
- Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
- Assessment must maintain academic standards.
Assessment Summary
* The specific due date for each assessment task will be available on MyUni.Assessment Task Weighting (%) Individual/ Group Formative/ Summative Due (week)* Hurdle criteria Learning outcomes Further information will be available prior to the start of the Semester. Total 0
This assessment breakdown complies with the University's Assessment for Coursework Programs Policy.
Assessment Detail
No information currently available.
Submission
No information currently available.
Course Grading
Grades for your performance in this course will be awarded in accordance with the following scheme:
M10 (Coursework Mark Scheme) Grade Mark Description FNS Fail No Submission F 1-49 Fail P 50-64 Pass C 65-74 Credit D 75-84 Distinction HD 85-100 High Distinction CN Continuing NFE No Formal Examination RP Result Pending Further details of the grades/results can be obtained from Examinations.
Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.
Final results for this course will be made available through .
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Student Feedback
The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.
SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy (http://www.adelaide.edu.au/policies/101/) course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.
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Student Support
- Academic Integrity for Students
- Academic Support with Maths
- Academic Support with writing and study skills
- Careers Services
- Library Services for Students
- LinkedIn Learning
- Student Life Counselling Support - Personal counselling for issues affecting study
- Students with a Disability - Alternative academic arrangements
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Policies & Guidelines
This section contains links to relevant assessment-related policies and guidelines - all university policies.
- Academic Credit Arrangements Policy
- Academic Integrity Policy
- Academic Progress by Coursework Students Policy
- Assessment for Coursework Programs Policy
- Copyright Compliance Policy
- Coursework Academic Programs Policy
- Intellectual Property Policy
- IT Acceptable Use and Security Policy
- Modified Arrangements for Coursework Assessment Policy
- Reasonable Adjustments to Learning, Teaching & Assessment for Students with a Disability Policy
- Student Experience of Learning and Teaching Policy
- Student Grievance Resolution Process
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Fraud Awareness
Students are reminded that in order to maintain the academic integrity of all programs and courses, the university has a zero-tolerance approach to students offering money or significant value goods or services to any staff member who is involved in their teaching or assessment. Students offering lecturers or tutors or professional staff anything more than a small token of appreciation is totally unacceptable, in any circumstances. Staff members are obliged to report all such incidents to their supervisor/manager, who will refer them for action under the university's student鈥檚 disciplinary procedures.
The 成人大片 is committed to regular reviews of the courses and programs it offers to students. The 成人大片 therefore reserves the right to discontinue or vary programs and courses without notice. Please read the important information contained in the disclaimer.
