Biomanufacturing - Bio011- Introduction to Regulatory Affairs
About the program
Objectives
• Approach to Canadian and global regulations, regarding highly regulated products.
• Acquire the vocabulary specific to Regulatory Affaires.
• Know the different players governing healthcare systems linked to regulated industries and markets.
• Know how to navigate the legal text to find useful information, to interpret and apply regulations.
• Develop and manage regulatory submissions.
Prerequisites
This course provides you with the insight and knowledge to access an entry-level to mid-level career in regulated industries in Canada. It provides professionals with the opportunity to have their personal experience and competencies extended.
Concentrating on safeguarding both individuals and the environment, experienced professionals in this domain contribute positively to the welfare of the public.
Understand the regulatory environment here in Canada and its socioeconomic aspects, and an exploratory overview of our neighbors and economic partners such as USA and Europe.
This program is well-suited for professionals who:
• Communication skills.
• Analytical and critical thinking and are detail oriented.
• Able to analyze, evaluate and apply relevant information from a variety of sources.
• Have a strong interest in protecting the safety of people and the environment.
Who Should Attend:
• Quality Assurance, Regulatory affaires and regulatory Compliance Professionals
• Professional with background in Biology, Biochemistry, chemistry, Medicine, Legal
Course Attestation and Professional Development