Pharmaceutical Quality Assurance & Regulatory Affairs

QARA

  • Quality Assurance is critical to the success of product development and manufacture and the maintenance of regulatory compliance. This course is designed to provide participants with extended knowledge of Quality Management, Quality Assurance and Quality Control and to highlight the challenges associated with QA in pharmaceutical field.  In this course it clarifies the roles and expectations of Quality Assurance throughout the entire process, from development through audits and inspections. Students will gain a wide range of knowledge of quality assurance guidance: GMPs, GLPs, ICH, GDPs, how to write SOPs, do investigation, product complaints, product recall, returned goods, change control and CAPA.
    In this program it offers specialized knowledge required as regulatory affairs professionals who work in Pharmaceutical, biotechnology, medical device and food companies. This course will give participants the skills necessary to work with regulatory agencies worldwide from conducting clinical trials overseas to filing efficient, compliant submissions with foreign regulators. The primary focus is on regulatory affairs in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drug Administration (FDA), but it also discusses the regulations in Europe, Japan and Australia. In increasingly global market, understanding of global regulations is more important than ever.

  • 28 weeks (560 hours) instructor-led full time training
  • Degree in science, health science, pharmacy or similar fields.
    or a diploma with experience in clinical research or regulatory affairs

  • The Pharmaceutical Regulatory Affairs and Quality Assurance Program focuses on knowledge of regulatory strategic considerations and principals and practices of the pharmaceutical quality assurance. After the completion of the program students will be eligible to apply in the following industries: 
    •    Pharmaceutical companies
    •    Food products industry
    •    Chemical products industry
    •    Federal and provincial governments
    •    Clinical Research Organizations
    •    Environmental Laboratories
    •    Cosmetic industry
    •    Natural health product companies
    •    Quality Assurance Specialist
    •    Quality Assurance Coordinator
    •    Quality Assurance Associate
    •    Quality Assurance Auditor
    •    Quality Assurance Document/Date Reviewer
    •    Quality Assurance Inspector
    •    Regulatory Affairs Assistant
    •    Regulatory Affairs Associate
    •    Regulatory Affairs Specialist
    •    Regulatory Compliance Associate
    • Develop and conduct programs of sampling and analysis to maintain quality standards of raw materials, chemical intermediates and products 
    • Conform to applicable SOP’s, GMP and GLP requirements
    • Ensure that a company's products comply with the HPFB, FDA and ICH regulations regulations
    • Develop and maintain strict compliance (policy guidelines, development of a standard compliance program & current Good Manufacturing Practices) 
    • Keep abreast of international legislation, guidelines and customer practices
    • Undertake and manage regulatory inspections
    • Connect different information to improve operational efficiency & performance and good communication with FDA performing an active role in hosting an FDA inspection
    • Review company practices and provide advice on changes to systems
    • Interpret quality related requirements to drug substance (synthesis, characterization, impurities) and drug product
    • Develop specifications (substance, product) and to improve documentation for pre-clinical and clinical work
    • Examine requirements and critical issues regarding non-clinical studies
    • Summarize all major steps and elements to the drug development process and to demonstrate ability to communicate in professional terms about the drug development process
    • Submit license and clinical trials applications to authorities to strict deadlines 
    • B.S. Degree in Chemistry /Pharmacy/Biochemistry/Life Sciences or related area or college diploma in chemistry
    • Experiences in Chemical Laboratory, Quality Control, Quality Assurance or Regulatory Affairs
    • To manage analytical method validation and analytical testing support
    • Proficiency in computer skills and lab software
    • Good verbal and written communication skills
    • Team player and other soft-skills
    • Working knowledge of pharmaceutical regulations quality/compliance issues related to different departments
    • Ability to work on quality/compliance issues of moderate scope where analysis of data requires evaluation of identifiable factors
    • Support FDA and International Regulatory inspections, preparations and corrective actions as needed 
    • Work on drug and or device regulatory submissions to FDA and communicates this regulatory strategy and status of implementation
    • Results oriented, excellent time management skills, self-motivated, team-oriented, attentive to detail, and be able to work well under pressure to meet schedule requirements 

 

Contact us

CANADA-TORONTO
505 Consumers Road,
Suite 500 Toronto, ON M2J 4V8

TEL: + 1 416 821 4876
+ 1 647 996 5876
FAX: +1 416 916 8786
Email: info@pharmamedical.ca
www.pharmamedical.ca

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