David Blicq firstname.lastname@example.org update 05/15/2013) DIRECTORY I BIO I NOTICE BOARD
The following page describes what skills you can expect to develop as a result of successfully completing "Industrial Biosciences". These skills are often refered to as "Learning Outcomes", which describe tangible skills.
Included below are the following topics:
- Course Objective
- Course Organization
- Theory / Lecture example topics
- Student Assessment
- Practical Laboratory Component
- General Learning Outcomes
- Specific Learning Outcomes
1. Course Objective:
To provide a fundamental understanding of the requirements and procedures involved in the production, control, maintenance and development of the products of bioscience. These products are often produced under tightly controlled conditions and demand an exceptional degree of accountability during development and manufacture. Typical products could include pharmaceuticals, purified enzymes / biochemicals, nutraceuticals or agri-food materials. This course will provide an understanding of the relationship between the production, analytical and quality control functions needed to ensure quality standards are maintained and that complete accountability is achieved for all aspects of research / development, analysis and production.
2. Course Organization:
The course is designed to provide both an understanding of the theory behind the industrial requirements of the biosciences and deliver hands-on instruction in the procedures needed to consistently maintain the well-documented controls essential in the research /development and manufacture of such products.
Delivery will employ two main streams: a traditional lecture format (including both theoretical and practical / laboratory components) and an alternative lecture / theory module delivered via the Internet (for individuals currently employed seeking to upgrade their skills off-campus).
3. Theory / Lectures:
Examples of both the theoretical and the practical components include:
- Standard Operating Procedures (S.O.P.) – includes both specific work instructions and correct use of forms
- Standard Test Methods (S.T.M.) – includes both specific work instructions and correct use of forms
- Templates – the development and use of templates to improve documentation activities
- Record Maintenance – for production (batch / lot records, process operations); analysis and quality control
- Definition – why, what, and how successful audits are conducted
- Responsibilities – an examination of the various duties and expectations for participants
- Audit Review – assessment, prioritization and incorporation of audit findings
- Independent review / assessment of results / information
- Test / establish extremes / limitations
- Lock-in of operating conditions
- Pilot scale studies / research
- Scale up procedures
- Problem identification; solution prioritization
4. Student Assessment
Two (2) SOP (standard operating procedures will be completed by the student, each worth 20% of the final grade. One term paper will be worth 60% of the final grade. Students will request the assignments as they reach each "ASSIGNMENT MARKER" in the on-line curriculum.
5. Practical Laboratory Component (currently unavailable)
The project / laboratory component of the SRM program will provide a dynamic environment in which the student can apply their developing science management skills. Successful completion of the project component will be a fundamental requirement for program completion.
Working directly with the research manager / instructor(s), the student will develop documentation templates (IS0 format) to control all scientific activities. Individuals currently employed in a relevant work environment may request to develop actual quality system documentation for their institution of employment. Students will learn to design, organize, manage and review scientific activities, and will be responsible for the development of effective documentation to provide complete accountability for all projects. Students will learn how to create, maintain and focus productive scientific / research activities.
6. General Learning Outcomes:7. Specific Learning Outcomes
Documentation Skills – the ability to generate highly relevant documentation to monitor all aspects of scientific research / activities with an exceptional level of accountability. Science Management Reasoning Skills – the ability to prioritize activities, to review and assess functional progress, to set and attain realistic goals in expected time periods, to critique and improve research / action plans to meet changing requirements Resource Assessment and Control Skills – the ability to accurately estimate technical resources and apply them effectively in order to maximize activity effectiveness. Human Resource Management Skills – the ability to work as a team-builder to develop an environment of scientific success. To merge institutional and personal goals of research / scientific activity participants to generate "research momentum". Organizational Skills - the ability to organize effective meetings, communications, and management activities within the framework of an organizational hierarchy. To also manage multiple tasks in an effective and controlled manner in order to achieve both short and long-term goals.
Upon course completion, the student should be able to:
Prepare and follow Standard Operating Procedures (S.O.P.)
Prepare and follow Standard Test Methods (S.T.M.)
Develop and use Templates for research management
Maintain and organize Records
Control and manage Research Projects
Develop and implement Research Project Proposals
Establish timelines and allocate resources for Research Projects
Implement Trouble shooting (problem identification; solution prioritization)
Practical Laboratory Component (currently unavailable)
Students will be able to design, organize, manage and review scientific activities, to develop effective documentation, and demonstrate complete accountability for all projects. Students will be able to develop, maintain and focus productive scientific / research activities. Project Completion is a necessity for SRM graduation
8. Learning Strategies:
On completion of this module the student will be able to develop, coordinate and manage applied research / bioscience production activities. Below is a list of strategies, resources and outcomes expected by course completion.
Specific Learning Outcomes
The student will be able to: