GDP and RP Auditor
Master pharmaceutical GDP and RP auditing with ISO 19011 training and practical case studies in this auditing course, developed with Responsible Persons and GDP professionals in mind
Our new two-day practical GDP and RP Auditor training course has been written from the ground up to specifically meet the audit responsibilities for busy Good Distribution Practice (GDP) professionals and Responsible Persons (RPs).
GDP professionals who attend our other courses regularly feedback to us that they have an obligation to conduct audits in the GDP Quality System, but they lack the know-how and experience to implement an effective audit programme, or indeed, know where to start in planning and conducting an audit. In addition, GDP guidelines state that auditor training is a recommended intervention for GDP professionals.
Key Topics
All sessions have practical exercises to help the learners apply the techniques. The course covers the following topics:
- Types of audits and GDP auditing standards and guidelines
- Setting up and managing a risk-based annual audit programme
- The audit cycle – planning, initiating, conducting audits
- Preparing and planning for your audits, including checklists
- Auditing techniques and auditor competencies
- The audit process- opening meetings, the audit, closing meetings
- Writing clear non-conformances and concise audit reports and follow-ups
- Audit role play
Learning Outcomes
After two days of practical training with our expert tutors you will have the ability to:
- Apply the core regulations and standards you are obliged to audit against
- Set an effective risk-based annual audit programme to cover the core GDP system to meet statutory obligations
- Plan and conduct individual audits with clear audit criteria and audit agendas
Who should attend?
This course is suitable for the following professionals:
- GDP professionals who have responsibility for the audit programme
- Responsible Persons who need to set audit programmes and either commission or conduct GDP audits
- GDP auditors
- Other GDP professionals involved in the GDP audit cycle
Register Interest in Life Science Training
Use the form below to register your interest in our RSSL Life Science training courses. Please select the course you are interested and we will be in touch with more information on dates and costs etc.