PSCC - Pharmaceutical Quality Assurance and Regulatory Affairs Program

Quality Assurance and Regulatory Affairs Diploma Program

The 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/QC in this environment. Quality Assurance is critical to the successful development and manufacture of products and the maintenance of regulatory compliance. This course 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.

This program is a unique in offering specialized knowledge required to help biotechnology, medical device, pharmaceutical, and food companies. This course will give participants the skills necessary to work with regulatory agencies world wide � 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 (HPFIB) and the US Food and Drug Administration (FDA), but as well as the regulations in Europe, Japan and Australia. In increasingly global market, understanding of global regulations is more important than ever.

Program Length (28 weeks (560 hours) instructor-led full time training)

Admission Requirement

Applicants must have degree in science, health science, pharmacy or similar fields. A diploma with experience in clinical research or regulatory affairs also may be considered for admission to the program. Individuals who are already employed in the health sector who are considering a career change or who already work in clinical research may benefit from the part time program by selecting individual courses relevant to their learning needs. Information about current part time offerings can be obtained by contacting program staff.

Typical Employer (Career Opportunities)

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

Job Title

   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

Duties and Responsibilities

Understand analytical techniques such as titration, solvent extractions, GC, HPLC and dissolution equipment, and other lab instruments as required

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

Skills/Experience Required (Employer Requirements)

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

Through knowledge of HPLC, GC, UV and dissolution systems

Good knowledge of GMP, GMP, ICH and FDA regulation

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

Working Conditions
Professional environment in different industries; traveling

Physical Demand
Light lifting in the laboratory environment

Salary Range
$45.000-55.000

Typical Work Hours
7.5-8 hours