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Graduate Certificate in Regulatory Affairs

Graduate Certificate in Regulatory Affairs

at Humber College North Campus Canada

Overview

Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related products. 

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and how these are linked to the federal government and provincial formularies.

Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.

The pharmaceutical industry is facing constant development. As society is aging more focus is being given to the development of new drugs and the improvement of health care. The comprehensive training we provide, combined with previous degrees and work experience, make our students highly marketable. Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.

Read More

30

Application Processing Days

Post Graduate

Program Level

Fact & Figures

Full Time On Campus

Study Mode

12

Duration

Humber College North Campus

Location

Graduate Certificate in Regulatory Affairs Assistant Fee

$26202

Tuition Fee

$12000

Average Cost of Living

$75

Application Fee

2

Backlogs Allowed

Graduate Certificate in Regulatory Affairs Admissions Requirements

  • Minimum Level of Education Required: To be accepted into this program, applicants must have a Bachelor’s Degree in a related field or equivalent.
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Where would you like to study*

Work Permit Canada

Students who wish to work in Canada require a work permit to do so. A student in Canada can work part-time during the course of his studies and full-time during holidays and semester breaks and post the completion of their course/program.

Rules for getting a part-time work visa in Canada

You can also work part-time on campus at your university.

Work Permit

Duration

Your part-time work permit will be valid for as long as you have a valid study permit.

Working Hours

20 Hours/Week

As a full-time student, you can work for a maximum of 20 hours a week. However, you can work full- time during holidays and breaks.

Document Required to Work in Canada

List

To apply for a work permit, you will need a study permit that mentions that you are allowed to work part-time on campus.

Social Insurance Number

Study Permit

You will need a Social Insurance Number (SIN) to Service Canada. if you wish to work in Canada during the course of your studies. To apply for the same, you need a valid study permit, and you should be a full- time student at a recognized university.

You can work part-time off-campus if you are studying in the Quebec province.

Duration of Work Permit Canada

Your part-time work permit will be valid for as long as you have a valid study permit.

Work Hours Canada

As a full-time student, you can work for a maximum of 20 hours a week. However, you can work full- time during holidays and breaks.

Document Required to Work in Canada

To apply for a work permit, you will need a study permit that mentions that you are allowed to work part-time on campus.

Social Insurance Number

You will need a Social Insurance Number (SIN) to Service Canada if you wish to work in Canada during the course of your studies. To apply for the same, you need a valid study permit, and you should be a full- time student at a recognized university.

Working after completing your course

In Canada, you will need a work permit to get a full-time job in Canada after finishing your studies. You chose a work permit like the Post-Graduation Work Permit (PGWP) if you wish to stay back in Canada and work full-time.

Visit Government of Canada Website for more detail

Post-Graduation Work Permit (PGWP)

The Post- Graduation Work Permit (PGWP) allows you to work for three years in Canada if you have completed a two years degree or more.

Application

how can i apply

You can either apply online or download the form and mail the application along with the required documents. Pay your fee and then wait for the decision to come.

Application Documents Required

List

To apply for the work visa, you need a degree from a recognized and accredited Canadian University along with an intention to stay and work in Canada only temporarily.

When to Apply?

One can apply for the full-time work permit in the first three months post the completion of their course during which the study permit is still valid.

How long does it take?

90 days

You will have to wait for 90 days for the decision on your work permit.

Duration

3 Years

The work permit is valid for 3 years if you have completed a two years degree program or more.

Fees

CAD 255

The fee for the work permit is CAD 255 plus the holder fee and the work permit processing fee.

Monthly Wages

CAD 1,600

An applicant is guaranteed a minimum salary of CAD 1,600 per month while working in Canada. This amount though varies on the job and the province you are working in.

Work Hours Canada

No Limit

There is no maximum limit, and you can work for as many hours as you want on the full-time work permit.

Required Documents

List

To apply for the work visa, you will need the following documents:

  • Forms: IMM 5710, IMM 5476 and IMM 5475;
  • Graduation Proof
  • Proof of payment of work permit fees
  • Copies of your travel and identification documents, passport pages and current immigration document.

Till a decision is made on your work visa, you can continue to work full time. All you need to have is your completed degree, should have applied for the permit before the expiry of your study permit and you should be allowed to work off-campus.

Information

Disclaimer

The information provided about the work permit is true and complete to the best of our knowledge. All recommendations are made without any guarantee on the part of the author or the publisher. The author and the publisher, therefore, disclaim any liability in connection to and with the use of this information.

Detailed Program and Facts

30

Application Processing Days

Full Time On Campus

Program Intensity

Post Graduate

Program Level

12

Duration

Study Visa

Student Visa For Canada

Any student who wishes to study in Canada requires a student visa. Some of the essential information for the application process is given below.

When Should I Apply?

4 to 6 months

Ideally, one should apply for the study permit at least 4 to 6 months before the commencement of your course/program.

Bank Account

No Need!

There is no need for a blocked bank account to apply for a student visa to Canada.

Duration of visa

Course Duration + 3 Months

The student visa is valid for the entire period of your course plus three months.

Time to Wait for Visa

35 Days

It takes time. It might take up to 35 days post your interview for the application process to complete and for you to finally receive your visa.

Appointment

Required

It varies from applicant to applicant, but one may have to take part in one or two visa appointments, namely a medical examination and a visa interview.

How you can apply

Application Process

An applicant can either apply online or offline by visiting a visa application centre and submitting their documents. After the analysis of your application, you might be called for an interview.

Fee

Visa Fee

The visa application fee for Canada is CAD 150.

Minimum Funds

833 CAD, 917 CAD

You require a minimum monthly amount to be deposited into your account to prove that you can sustain yourself while studying in Canada. If you are studying in Quebec, you need to have a monthly minimum of CAD 917, and if you are studying in a province except for Quebec, you need to have a minimum of CAD 833 per month.

Any other expenses

Required

You will have to pay a medical examination fee and a visa application service fee to the tune of CAD 15 if you visit a visa application centre to apply for your visa.

Medical Examination

Required

One has to undergo a series of medical examinations to be deemed fit for a student visa of Canada. The tests mostly include blood and urine tests, chest x-rays and other organ checkups.

Language Skills

Not Required

one doesn’t need to prove their language skills in applying for a Canadian Visa.

Disclaimer: The information provided about the work permit is true and complete to the best of our knowledge. All recommendations are made without any guarantee on the part of the author or the publisher. The author and the publisher, therefore, disclaim any liability in connection to and with the use of this information.

English Test Requirement

6.5

Minimum Overall Score

88.0

Minimum Overall Score

61.0

Minimum Overall Score

Other Courses by Humber College North Campus,Canada

Public Safety and Legal Studies

Graduate Certificate in Regulatory Affairs

Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related products. 

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and how these are linked to the federal government and provincial formularies.

Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.

The pharmaceutical industry is facing constant development. As society is aging more focus is being given to the development of new drugs and the improvement of health care. The comprehensive training we provide, combined with previous degrees and work experience, make our students highly marketable. Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.

12 month

Duration

$ 26202

Tuition

Creative Arts & Design

Certificate in Design Foundation

Humber’s Design Foundation certificate program provides you with the skills to focus your creativity as you begin a career in design.  If you have a clear interest in visual art and design, but want to upgrade or build your portfolio of work, or explore various design disciplines while considering your future career, this is the program for you. With a deep scope of experience in a variety of design facets, our faculty provides you with an industry-current perspective of your work while offering you a broad based preparatory design education. You will develop design skills, techniques and processes; and learn about various professional career choices while developing and refining your comprehensive portfolio. Your training is led by professional designers from a variety of disciplines in a curriculum that features courses in:

  • 1, 2 and 3-Point perspective drawing
  • 2D and 3D principles
  • Colour theory
  • Interior design
  • Industrial design
  • Graphic design
  • Design software such as Photoshop, Illustrator and AutoCAD

You will also work in professional-quality labs, developing skills that will give you the hands-on experience employers want.

Designers influence the development of products, the packages they come in and the marketing materials used to promote them. We also rely on designers to plan all types of buildings and to create inviting spaces within them.In Toronto’s vibrant creative sector, the demand for talented and skilled designers is strong. Your generalized training in the many aspects of design may be an effective launching pad to more specialized design study in various fields including industrial design, interior design, interior decorating, graphic design, architecture, civil engineering or building technology.

12 month

Duration

$ 16394

Tuition

Fashion is an international business, and Humber’s Fashion Arts and Business diploma program places an emphasis on retail operations from both domestic and international perspectives. You will study marketing, store planning and merchandising, brand management, marketing, social media, event planning, and retail buying. You’ll also learn fashion trend forecasting, sales techniques, and colour and styling analysis while attaining basic knowledge of fashion products and fashion promotion. These skills are then applied to product launches, planning merchandise assortments, styling fashion shoots and the production of fashion events.

Our advisory committee provides regular review and input of curriculum ensuring our program is always on the cutting edge of industry developments.

In first year, courses in the business of fashion – marketing strategies, product knowledge, trend forecasting and web merchandising – give students an overview of this multibillion-dollar industry. In second year, students build on the skills developed on the foundation with wholesale sales, retail buying and operation, photo styling and event planning and budgeting.

Learning Outcomes:

Upon successful completion of the program, a graduate will:

  • Differentiate the purposes and functions of and the relationships between various elements within the structure of the fashion industry in order to identify business opportunities, challenges and solutions.
  • Define and use correctly the terminology and language of fashion from a business and art perspective in order to communicate effectively with the range of stakeholders in the fashion industry.
  • Identify artistic and business trends in order to capitalize on emerging opportunities throughout the stages of product development, manufacturing, distribution and promotion.
  • Respond to current market conditions based on detailed analysis of company and/or industry reports.
  • Design promotional materials and events using current digital technologies and styling methodologies in order to advance fashion arts and business objectives.
  • Employ professional practices which support current business strategies and plans adhering to legal, ethical and sustainable standards appropriate to the fashion industry.
  • Create a variety of strategic planning deliverables for achieving measurable goals for fashion merchandising, marketing, operations, finance and sales.
  • Conduct vendor negotiations, budgeting, critical path analysis, communications and operations for effective fashion-related promotional events.
  • Tailor visual and verbal presentations suitable for various stakeholders (e.g. buyers, senior managers, vendors, customers) to meet their specific requirements.
  • Generate social media strategy and content for marketing purposes in order to build product and brand awareness.
  • Negotiate mutually profitable business-to-business transactions between parties in the supply chain in order to maximize cost effectiveness.
  • Develop professional development plans to set career goals based on self-assessment of strengths, interests and opportunities.

24 month

Duration

$ 16414

Tuition

Hospitality, Tourism, Wellness Leisure & Sports

Diploma in Nutrition and Healthy Lifestyle Promotion

Humber’s Nutrition and Healthy Lifestyle Promotion diploma program prepares you for a career promoting health and wellness to individuals and groups of all ages, and encouraging people to live a healthier lifestyle. Unique in nature, it is the only diploma program of its kind in Canada. In this program you will:

  • Develop an understanding and knowledge of general and clinical nutrition, sport nutrition and physiology
  • Gain valuable hands-on experience coaching and conducting health promotion seminars and workshops in our unique Humber Centre for Healthy Living
  • Learn how to relate knowledge of essential nutrients into practical nutritious eating for clients by discovering the techniques of healthy cooking, food demonstration, recipe development and menu planning
  • Nutritionally assess and analyze menus and recipes integrating financial, health and culinary criteria

You will have the opportunity to join student branches of the Canadian Association of Foodservice Professionals (CAFP). As student members, you will build on your networking skills in foodservice organizations and have the opportunity to apply to association-sponsored bursaries and scholarships.

This innovative program will provide you with the education and experience to work in the rapidly growing health and wellness industries. The curriculum is founded on evidence-based nutrition information and is taught by registered dietitians and other regulated health-care professionals.

Learning Outcomes
Upon successful completion of the program, a graduate will:

  • Conduct assessments of nutritional status, well-being, and lifestyle for clients low to moderate risk and effectively communicate assessment results.
  • Apply knowledge of fundamental and clinical nutrition to prescribe appropriate diets, active living, and lifestyle programs to enhance nutritional status, health, and well-being of clients of low to moderate risk.
  • Utilize appropriate interviewing and behavior change coaching and counseling skills to promote or enhance nutritional status, health, active living, and well-being of clients.
  • Collaborate with individuals in the selection and adoption of strategies to improve their nutritional status, health, and well-being.
  • Develop, revise and evaluate food items, recipes, and menus to maximize the nutritional content of healthy eating plans.
  • Apply knowledge of the global food supply, sustainability and food technology in the development and revision of recipes, menus and healthy eating plans for individual and groups of clients.
  • Develop, implement, and evaluate programs and events which respond to identified needs and interests of clients and maximize the benefits of diet, health, and well-being.
  • Contribute to community health promotion strategies to improve the health of individuals, groups, organizations and institutions.
  • Assist in the development of business plans for health and wellness programs, activities, and facilities.
  • Develop and implement risk management strategies to ensure standards and regulations for food safety and sanitation are met.
  • Implement ethical practices and ongoing personal and professional growth and development plans.
  • Interact effectively and professionally with clients, staff, and volunteers in health and wellness programs, activities, and facilities.

Work Placement
All students will complete a 15-week experiential learning course involving our on-campus Humber Centre for Healthy Living. Components of this placement include:

  • Nutrition awareness events: students develop and deliver group educational workshops, displays and sessions for community, business and industry partners in various settings
  • Practising nutrition coaching to Humber students and staff: students provide nutrition education for clients and support them in developing and achieving their health and nutrition related goals. This includes diet assessment, recommendations and development of a client tool kit

24 month

Duration

$ 16414

Tuition

Humber’s Cabinet Making certificate program, located at the Humber Centre for Trades & Technology, provides you with the knowledge and skills to construct and install basic cabinets, as well as build traditional furniture using recognized trade practices. By completing a series of woodworking projects, you will explore various types of joinery and construction techniques using hand tools, portable power tools, stationary machines, as well as computer-based technologies. Time management skills and the ability to work to a deadline are developed and stressed throughout the program.

Graduates of the program will be able to produce shop drawings, calculate a list of materials, cut out and assemble basic cabinetry or furniture and also apply a finish. Graduates are able to safely operate most common stationary woodworking machinery, as well as run a number of CNC machines in a limited capacity.

12 month

Duration

$ 16394

Tuition

Health Sciences, Nursing and Emergency Services

Diploma in Biotechnology

Humber’s Biotechnology diploma program prepares graduates with the transferable skills needed to build successful careers in a variety of biotechnology and research sectors. The program balances theoretical understanding with experiential practices in specific laboratory skills needed by employers. These practical components are the focus of the program and are developed and reinforced through an integration of practical laboratory experiences. Integrative laboratory projects are designed to simulate a real life experience through translation of theory to practice. The program provides a valuable specialization to students interested in life sciences programs without having to go elsewhere for practical laboratory skills training.

Students will benefit from:

  • Laboratory skills development linked to industry demands
  • Extensive applied/hands-on laboratory experience
  • Simulated learning environments
  • Integrative project work that links applied and academic fields (simulating real work experiences)
  • Acquiring a recognized skill set applicable to a wide variety of employment opportunities
  • A unique integrated approach
  • Learning to operate laboratory equipment stable in the field of science and biotechnology
  • Learning to adapt to the changing field and stay current

24 month

Duration

$ 16394

Tuition

Humber’s Journalism advanced diploma program is designed to produce dynamic storytellers who are immediately ready to work in a variety of media platforms as reporters, broadcasters, editors, producers and digital content managers. Our program is also ideal for those looking to go into communications or public relations.

As a journalism student, you’ll be given training in hands-on skills that are at the forefront of what’s happening in the industry today including reporting the news, creating broadcast stories, writing feature articles, capturing high quality images and creating compelling digital presentations. Our tight deadlines match industry standards. You will work individually and in teams in the classroom and in the field. You will learn from industry experts and media personalities. As well, you will get a solid grounding in media law and ethics.

We are constantly updating our curriculum to reflect the new reality of journalism in the digital age.

Our program features:

  • courses with a focus on digital media, online publishing and developing web content including social media
  • hands-on technical and production training including broadcast equipment, digital prepress, TV production and multimedia management
  • entrepreneurial skills advice for today’s highly competitive media communications market
  • real-life experience working on our online news site humbernews.ca, Humber Et Cetera campus news online, Radio Humber 96.9 FM, Humber TV and magazine productions
  • valuable industry exposure and contacts through work placements which help you build your network and resumé
  • experienced faculty working in industry bringing extensive and exclusive media connections

36 month

Duration

$ 16414

Tuition

Hospitality, Tourism, Wellness Leisure & Sports

Diploma in Baking and Pastry Art Management

Humber’s Baking and Pastry Arts Management diploma program, taught in our state-of-the-art baking and pastry labs, is designed to propel you into a career in the baking and pastry industry. Learn how to make impressive confectionery creations such as:

  • Chocolate sculptures
  • Wedding and specialty cakes
  • Tarts and pastries
  • Plated desserts
  • Artisan breads and breakfast pastries
  • Petit fours
  • Ice cream, gelato and sorbets
  • Blown, pulled and cast sugar pieces
  • Large quantity production

You will gain hands-on experience working in various settings, individually and as a team member, creating baking and pastry delicacies. The first year of the program consists of foundational courses while in second year, you begin in-depth training in baking and pastry arts. You will learn the foundation of traditional and contemporary techniques in baking and pastry arts management exploring measurements, safety and sanitation, and various types of dough. As well, you’ll study the emerging opportunities of this specialized field, international trends and applications used in the industry. Areas of study in the program also include courses in business and career management, entrepreneurship, and computer applications for the food-service industry, as well as general education and communications courses. Our seven on-campus kitchen labs comprise the most modern facilities in the world. Among them are the award-winning culinary demonstration theatre and kitchen lab, induction cooking labs with high-tech exhaust and theatre-style seating and cooking demonstration area.

Qualified students will complete an unpaid work placement in the baking and pastry industry in the Greater Toronto Area for seven weeks in the fourth semester (40 hours per week). Students will also be able to apply for placements across Canada and Europe, which have jump-started many successful careers.

24 month

Duration

$ 16394

Tuition

Hospitality, Tourism, Wellness Leisure & Sports

Diploma in Recreation and Leisure Services

Humber’s Recreation and Leisure Services diploma program provides you with skills needed to start your career in government, not-for-profit and commercial recreation organizations. You will learn about recreation programming, special event management, staff management, facility operations, marketing and other services within the industry.

The curriculum is designed with industry collaboration, ensuring it is current and relevant. Within the program, students use ActiveNet software and PerfectMind, the most widely used registration management software in the recreation industry.

Students apply their skills by planning and implementing events for local community and charity organizations. A three-day leadership camp at the Ontario Educational Leadership Centre helps build communication and leadership skills while guest speakers, practical training and field trips provide added benefits in preparing you for the workplace.

Learning from professors, as well as managers and directors of recreation programs, centres and agencies will give you valuable exposure to the industry and training in current issues.

Work Placement

  • Qualified students will complete a work placement in Semester 4 – three days per week for 15 weeks (total of 250 hours). The school works with the student to find a placement with an industry partner. The placement occurs across industry sectors including professional sport associations, community and amateur sport governing bodies, and private sector sport organizations. These placements provide valuable experience and industry contacts.

24 month

Duration

$ 16414

Tuition

Health Sciences, Nursing and Emergency Services

Diploma in Fire Services

Humber's Fire Services diploma program teaches you the theory of fire science, fire prevention, safety, and physical and mental health while working in a collaborative environment. You will gain a well-rounded education in fire services and will acquire the knowledge, skills and abilities required by fire and emergency services. You will also develop personal resilience strategies to manage the rigours of this career.

This program does not educate you to become a firefighter. If you would like information on becoming a firefighter, see our Pre-Service Firefighter program.

Learning Outcomes
Upon successful completion of the program, a graduate will:

  • Design, interpret, problem-solve and modify technical projects related to fire protection.
  • Analyze the impact of legislation, fire standards, regulations, ethics, and guidelines on the operation of fire services
  • Use building construction documentation to evaluate safety hazards when responding to an emergency.
  • Advocate for fire services, fire health, safety and prevention to enhance public safety and awareness.
  • Apply relevant occupational health and safety regulations, legislation, policies and procedures, ethical principles and professional conduct in various workplaces.
  • Apply communication, teamwork and organizational skills to enhance the quality of service in fire services.
  • Analyze, within a Canadian context, the impact of historical practices and current trends on the operations in fire science.
  • Ensure maintenance of one’s physical and mental health and abide by the occupational standards of the firefighting profession.
  • Employ strategies, programs and interventions to provide help to an individual experiencing an acute mental health crisis as well as to address chronic stress related behaviours found in self and others.
  • Apply knowledge of human rights and freedoms legislation in all verbal and written interactions.
  • Work cooperatively in multidisciplinary teams to achieve mutual goals.
  • Develop and implement ongoing effective strategies for personal and professional development to manage the rigors of a career in Emergency Services.

24 month

Duration

$ 16414

Tuition

View All Courses by Humber College North Campus, Canada

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