Permanent Inspection Readiness Training
Rescop provides training on Permanent Inspection Readiness (PIR) to learn organizations on how to prepare for US or EU Competent Authority (CA) inspections and audits, and how to pass them successfully. Although, the focus of the training will be on FDA and EU GMP inspections of pharmaceutical products and ISO audits of Medical Devices, the followed approach is applicable to the other GxPs as well.
The training is suitable for people who do have a prominent role during CA inspections and audits and may include;
- Quality personnel involved in the hosting of the inspection / audit,
- Quality, Operational or Technical personnel who will be interviewed as process or system owner by the inspector/auditor,
- Personnel involved in formulating responses to inspection observations
The duration of the PIR training is 1 day and can be either provided as an on-site training or organized at one of the training locations of Rescop.
Permanent inspection Readiness Foundation
The PIR training is setup to provide an overall inside in the most important aspects of a CA inspection / audit, and how this information can be translated into an effective preparation program.
Topics that will be addressed during the training, concerns – but is not limited to:
- Why do CAs execute inspections / audits and what trends can we deduce from these inspections / audits?
- How do the Health Authorities like FDA and EMA / Notified Bodies execute their inspections / audits and what do we know from the inspector / auditor?
- What will be the scope of the inspection / audit and what are the items that will be subject to the inspection / audit?
- How to present the organization and processes to the inspector / auditor?
- Which Organizational / logistical aspects to address in the preparation of the inspection / audit (e.g. front and back office, communication method, tour through facilities, etc)
- How to prepare known – by the organization self-identified – issues to the inspector / auditor?
- What are the Do’s and don’ts during the inspection / audit?
- How to provide written responses to the reported observations?
- How to maintain inspection readiness and what are the elements of PIR?
Program Permanent Inspection Readiness Foundation
- Module A – Introduction on CA inspections / audits and trends
- Module B – Insight in the FDA and EMA inspection programs
- Module C – Inspection / audit preparations on site
- Module D – Responding to inspection / audit observations
- Module E – Basic Elements of PIR