Regulatory

Overview The " Testing of GxP Computerized Systems" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of testing strategies across the system lifecycle, emphasizing defect detection, risk management, and fitness for intended use. Participants explore both traditional and modern testing approaches, including scripted, unscripted, exploratory, and automated testing, with guidance on selecting the most appropriate method based on system impact and risk, the testing objective, and the nature of the component under test. The section highlights the…

Overview TThe " Quality Risk Management (QRM)" section of the GAMP ® Basic Principles (T45) training course provides a structured, science-based approach to identifying, assessing, and controlling risks throughout the lifecycle of GxP computerized systems. Grounded in ICH Q9 R1 principles, the module emphasizes risk to patient safety, product quality, and data integrity, while also considering business impact. Participants learn to apply a five-step QRM process from initial system impact assessment to ongoing monitoring of controls using approaches that evaluate hazards for severity…

Overview The " Regulations and Regulators" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of the regulatory landscape governing computerized systems in the pharmaceutical industry. It explores key global initiatives and regulations, including the FDA’s 21st Century CGMPs and EU GMP Annex 11, and emphasizes the shift toward risk-based, science-based, and quality systems-based approaches. Participants gain insights into the regulatory hierarchy from laws and regulations to guidance documents and learn how to apply these frameworks to ensure…

Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…

CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.