Lesson Code: OPE-1102 (PREMIUM LESSON) Interacting with the Inspector can be a major source of problems during a GMP Inspection. Proper behaviours and understanding the types of questions that an Inspector will ask are extremely important parts of your team's success. Using the very latest in e-learning technology and a scenario-driven approach, this e-Lesson explores the types of questions that are typically asked in a GMP Inspection situation along with appropriate responses. Additionally, the behaviors that should be exhibited by anyone interacting with an inspector are also explained and illustrated within a comprehensive and immersive scenario based on recent real-world inspections. A new point scoring system lets you take part in certain key questions & interactions with the inspector, with a verdict presented at the end to let you know how well you have performed.
Lesson Code: OPE-1101 (PREMIUM LESSON). An overview of the key concepts and terminologies associated with nonconformities, and the CAPA methodology used to address them as part of a company’s Quality System. Using a scenario-driven approach, the user is taken through the key steps of a CAPA process from identifying a problem to verifying the effectiveness of the solutions implemented to resolve it. In doing so, users will be better equipped to distinguish between corrections, corrective actions, and preventive actions. The concept of risk and categorization of nonconformities as minor, major, or critical is also covered as are regulatory expectations surrounding nonconformities and CAPA.