Shehara Fernando

• Prepare lecture material and deliver lectures to students for the courses 'Preparing regulatory submissions' and 'Communication in clinical research'.
• Provide Curriculum guidance to assigned group of professors.
• Evaluate and grade student's assignments, projects and final exams
• Initiate, facilitate and moderate classroom discussions to promote an open learning environment
• Plan, evaluate and revise course content, material, and instruction methods
• Maintain office hours to provide additional support and assistance to students
• Support students in the use of eConestoga, the learning management system (D2L), as well as maintain course materials within this system.
• Ensure student awareness of course objectives, instructional approach, and evaluation systems

• Prepare lecture material and deliver lectures to students for the courses 'Health and Biosafety Regulations' and 'Bioethics in Life Sciences'
• Evaluate and grade student's assignments, projects and final exams
• Initiate, facilitate and moderate classroom discussions to promote an open learning environment
• Plan, evaluate and create course content, material, and instruction methods
• Maintain office hours to provide additional support and assistance to students
• Support students in the use of Moodle as well as maintain course materials within this system
• Ensure student awareness of course objectives, instructional approach, and evaluation systems

-Review and reinforce learning activities using lesson plans and learning strategies developed by the teacher/team to help students master concepts and skills.

-Facilitate student learning individually and in small groups.

- Facilitate student attention and re-focus/redirection back to the lecture.

- Provide clarifications regarding course material/instructions/reminder for next class

- Assist student with note-taking, communication support to faculty and provide support with group work.

• Generated the following templates to streamline validation activities at a global level:
• Created protocol and report templates for Process Validation (general and filling)
• Created protocol and report templates for cleaning Validation (general and degradation studies)
• Created report template for quality reviews

• Prepared and filed regulatory submissions as appropriate based on internal method of categorization
• Managed change requests initiated internally and externally
• Performed assessments of new or revised products change requests
• Responded to enquiries from regulatory bodies
• Generated annual report of product changes
• Created and conducted training and development presentations for internal staff on GMP and GDP

• Created project specific Study Protocols & Reports ensuring compliance with internal Standard Operating Procedures & Health Canada and FDA guidelines
• Created Study Protocols for Regulatory Affairs Submissions and responded to inquiries and deficiency letters by Health Canada
• Conducted statistical data analysis of laboratory data using WinSPC statistical software
• Revised and updated relevant Standard Operating Procedures pertaining to the department
• Created a database consisting electronic copies of all completed projects thereby improving departmental efficiency
• Initiated and lead a project to ensure continuous audit readiness