Pharmaceutical Quality Assurance

Course information for - 2025

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Quality assurance plays a vital role in maintaining product integrity and compliance in the cannabis and pharmaceutical industries. As a result, professionals with comprehensive training in pharmaceutical quality assurance are in high demand. This program is designed to provide an in-depth understanding of QA concepts and the critical role QA plays within pharmaceutical organizations. The training covers a wide range of essential topics, including common quality applications, tools, processes, and systems specific to the industry. Throughout the program, students will explore the foundations of quality, key quality elements, and the application of statistical methods. They will also learn about document systems, SOPs, and quality audits. Additional modules cover validation regulatory requirements, the importance and types of validation, and the structure of a validation program. Participants will gain insights into ISO standards, GMP guidelines from Health Canada, the FDA, and HPFBI, and best practices for product recall, complaints handling, and record keeping. The course concludes with detailed instruction on investigations, CAPA, gap analysis, and the integration of quality control and quality management systems. Learning Outcomes Upon successful completion of the course, students will be able to develop and implement robust quality assurance and quality management systems. They will be prepared to conduct supplier audits, investigate deviations, produce detailed audit reports, and manage CAPA and change control processes. Graduates will also be equipped to interact confidently with inspectors and prepare effectively for audits and regulatory inspections. Job Opportunities This training prepares students for a variety of quality-focused roles in the pharmaceutical industry, including QA Auditors, Change Control Coordinators, QA Associates, Managers, Technical Writers, Regulatory Affairs Associates, and Validation Specialists. Who Should Attend This course is ideal for entry-level QA professionals or individuals aspiring to move into QA roles. It is also well-suited for professionals with two to three years of experience working with GMP or ICH guidelines who wish to deepen their expertise. Internal auditors, audit team members, suppliers, and other professionals involved in audit processes will also benefit from this comprehensive QA training.
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