Question

You are in the process of establishing a new OECD GLP Recognised Facility. The facility will be capable of undertaking both in-life & analytical studies. NATA have notified you that they will soon be making an initial site visit to assess your facility and determine whether or not it is compliant with the OECD Principles of GLP. All of your staff are required to have a training file. Identify five (5) items you would expect to see in each staff member’s training file. Each item should be described in (maximum) one (1) sentence.

Answer 1

Answer:

Identify five items you would expect to see in each staff member's training file. Each item should be described in maximum one sentence.

Five items are:

• The OECD principles of Good laboratory practice and Guidance documents for Compliance Monitoring.
• Compliance of laboratory suppliers, Records of all inspection, methods to establish SOPs.
• Records of qualifications, traning records, experience and job description of each personnel
• Guidelines for Storage and Retention of Records and Materials.
• Training documents for hazard identification and risk assessment