Overview
This course provides an introduction to pharmaceutical GMP (PIC/S), quality management, regulatory environment, and product realization through market authorization, manufacturing, and lifecycle requirements.
Learning Objective
Gain an understanding of pharmaceutical GMP (PIC/S GMP Part 1) and its key requirements and how it relates to regulation and related Good Practices (GxPs).
Gain a fundamental understanding of the effects of GMP compliance on product quality.
Appreciate the importance of establishing an effective Pharmaceutical Quality System (PQS) or Quality Management System (QMS).
Acquire the basics of good documentation practices.
Understand Risk Management principles and how managing quality, safety and efficacy risks helps ensure patient safety.
Familiarize with requirements enforced by Regulatory Authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency, the Singapore Health and Sciences Authority (HSA), etc.
Target Audience
This course is suitable for all job roles within the pharmaceutical industry or for those who are looking to gain entry into this industry. These include roles in pharmaceutical research and development (R&D), onsite dispensary/warehousing, production, packaging, labelling, or quality control/quality assurance; or if you're in a role providing services or materials to such organisations (raw materials, APIs, filters, packaging materials, or consumables).
Facilitation
This course can be run as a live classroom or virtual (synchronous) instructor-led training. Please contact us for details.
Certificates
Please contact us for details.