Course set up:
Preparation before the session: You will be provided with pre-read material on audits and inspection definitions, such as the audit universe, legal requirements, audit types, audit strategy and program, and different roles in an audit/inspection. You are asked to prepare a 5-minute presentation of your PV area, to practice this element in a small group. Finally, an optional task consists of collating certain data in advance of the course, which will be discussed during the course. Make sure to set aside time for preparations in advance of the course. Estimate two hours, depending on your previous experience and knowledge. More detailed instructions will be sent out well in advance.
During the session: We are using a dynamic approach in our training, with practical exercises, alongside discussions on what this means in practice. You will also receive useful materials to help you apply your learnings back in your office.
After the session: The 1-hour personalized consultation is the perfect complement to this training. Our PV team will join you digitally or physically to discuss current issues or how to apply the learnings you obtained during the sessions in your own organization. Maybe you need strategic PV advice or, if you are new or alone in your PV role, you might rather prefer an hour of mentoring with a PV-expert. Contact us within 15 days after the on-site training to schedule this personalized 1-hour session.
- 9.30 -10.00 Optional meet and greet trainers and participants (coffee)
- 10.00-12.00 Workshop focus: Audit/Inspection Preparation /Readiness
- 12.00-13.00 Lunch
- 13.00-16:45 Workshop focus: Audit/Inspection conduct
- 16.45-17.15 Optional meet and greet PharmaRelations (Sandwich)