Question 1.1: What is seen as regular training in GDP; once per two years or a shorter timeframe?
Question 1.2: How should I review the training effectiveness? Qualitatively or quantitatively? Or by any other means?
Question 1.3: There are different types of wholesalers; for wholesalers with a warehouse it is clear that more training is needed per year. However, a commercial affiliate or trading entity only buys and sells the goods and outsources the warehouse and transport.
Question 1.4: The Responsible Person (RP) should ensure a training programme is in place and staff is trained. Can the training tasks be designated to the human resource department or should this be a part of the QA department?
Question 1.5: What would be the preferred content of qualification of the GDP trainer?
Question 1.6: What industry-standard training courses/certification are there for RPs that you can recommend?
Question 1.7: Activities to third parties - Are 3 to 5 GDP-related training courses per year then still needed?
Question 1.8: Are there requirements on training records for specific tasks (handling of deviations, change requests, complaints, release of product etc)?
Question 1.9: What are some examples of how to conduct the periodical assessment of the effectiveness of training?
Question 1.10: Regarding training effectiveness: is a knowledge check mandatory?
Question 1.11: Is it enough with a training plan for the QA team or does it need to be per employee?