Health Canada’s Health Products and Food Branch has a mandate of “minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products”. The FDA’s mandate is “protecting the public health by assuring that… human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective”. These are similar goals: protect the public by minimizing risks and maximizing safety and effectiveness of foods and drugs. Yet despite being borne from similar mission statements, these organizations behave very differently.
Why You Should Attend:
This webinar will discuss the organizational oversight for both various products from both regulatory bodies, regulatory submission, filings, and the regulatory process for both agencies. Participants will learn the requirements for supply chain entities, establishment licensing and quality systems for both agencies. Examples of consequences for non-compliance will be given from both regulatory bodies. This webinar will also discuss the interactions and potential implications for the pharmaceutical, biologics and medical device industries.
Participants should attend this webinar to learn the differences between these 2 organizations, regulatory and compliance obligations, and the effects of manufacturing under both organization's guidelines.
Areas Covered in the Session :
- FDA vs. Health Canada – Organizational Oversight for Different Product Types
- FDA vs. Health Canada – Regulatory Submissions / Filings and / or Regulatory Processes for Different Product Types
- FDA vs. Health Canada – Quality Systems & Establishment Licensing, Requirements for Supply Chain Entities
- Examples of Consequences for Non-Compliance with Regulatory Authorities
- FDA & Health Canada – Interactions & Potential Implications for industry
Who Should Attend:
- Manufacturing Departments
- Supply Chain Departments
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments
- Compliance Departments
- Documentation Departments
Course Director: JOY MCELROY
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing.
With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing.
Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.