Quality Control

High-level overview of quality documentation principles and practices. This course is the second in our three-part Quality series: Quality: Events Quality: Documentation Quality: Miscellaneous This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing solely on completing individual forms, this course explains why elements such as SOPs, batch records, change control forms, and supporting documentation are critical to a robust pharmaceutical quality system. You’ll learn the key principles behind effective document creation, control…

Overview The " Regulated Company and Supplier Activities" section of the GAMP ® Basic Principles (T45) training course explores the collaborative roles and responsibilities of regulated companies and their suppliers throughout the lifecycle of computerized systems. Emphasizing a risk-based, scalable approach, the module outlines governance, system-specific tasks, and the importance of leveraging supplier involvement in requirements gathering, testing, training, and maintenance. Participants learn how to assess suppliers using various methods from basic evaluations to on-site audits, and the…

Overview The " Infrastructure" section of the GAMP ® Basic Principles (T45) training course explores the foundational role of IT infrastructure in supporting GxP computerized systems and ensuring compliance with regulatory expectations. Participants learn the distinction between validation (for applications) and qualification (for infrastructure), and how to apply a good IT practice approach to infrastructure components. The module covers key concepts such as standardized platform builds, scalable qualification strategies, and automated approaches to improve efficiency and reliability. It…

Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.

This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.