Professions : Employee in pharmaceutical industry. An interactive tutorial scenario.
100 € before taxe / connexion.
Expertise developed by:
Attests to mastery of the knowledge and abilities associated with Level 2 of Good Manufacturing Practices collective e-learning training:
· UC1 – Deepening familiarity with the requirements of the pharmaceutical quality system, and analysing noncompliance with Good Manufacturing Practices using the 5 Whys to assure product quality and patient safety.
· UC2 Labour force – Making hygiene and gowning rules applied with appropriate PPE, according to production zone classifications.
· UC3 Process – Applying documentation best practices when preparing documents.
· UC4 Environment – Taking the necessary measures to minimise the risk of cross-contamination.
· UC5 Equipment:
– Applying line spacing rules to prevent cross-contamination.
– Acquiring problem resolution methods (6 Ws and Ishikawa diagram).
– Assimilating the concept of CAPA and continuous quality improvement.
· UC6 Materials – Identifying the compliance of materials according to documentary best practices, to ensure traceability of the product over the entire manufacturing process.
Exercises to reinforce acquisition and Learning :
4 downloadable PDF format pedagogical documents over this E-GMP Level 2 training course, with primary objectives and key points for training:
1. Essential principles for the work environment presented in skills unit UC4 Environment, with key points relating to the layout of premises.
2. The essential principles of good documentary practices presented in skills unit UC3 Process, with key points relating to preparing documents, and recommendations to prevent errors.
3. The essential principles of good practices presented in skills unit UC5 Equipment, with the following key points:
– Defining corrective action preventive action (CAPA).
– Presenting problem resolution methods: 6 Ws, Ishikawa diagram, and 5 Whys
– CAPA process and planning.
4. The essential principles of good practices presented in skills unit UC6 Materials, with the following key points:
– Penalties the authorities may impose at inspections.
– Vectors of contamination.
– Controlling contamination.
Evaluation methods :
The evaluation system is based on periodic multiple-choice quizzes positioned throughout the training course, and a final evaluation.
The percentage of correct answers must be equal to or greater than 80% to obtain the Level 2 E-GMP certificate.
Otherwise, with a score of 50% to 79%: the candidate may study the documents presented and retake the Level 2 E-GMP training course.
The number of attempts is noted on the evaluation result sheet.
Ability certificate :
6 ability units
Benefits of the training course :
· E-learning training format.
· Innovative pedagogical method with a serious game.