The training

This one day training focuses on preparing for government inspections and client audits. It includes pointers on the work to do beforehand, preparing your personnel how to answer
questions, designing your back office, how to properly receive inspectors, points of attention during the tour and successfully closing inspections/audits.

The training will be hosted by industry experts who have prepared and hosted numerous inspections and audits including the EU, WHO and FDA. This program includes a guest lecture
by an ex-government inspector from one of the leading EU national regulatory inspectorates.

If you are expecting client audits or regulatory inspections in 2023, this training will be exceptionally beneficial in ensuring you have a better understanding of the do’s and don’ts to obtain the best
possible outcome.

Target audience

This training is intended for those who work in the pharmaceutical industry and host or co-host audits and government inspections. This includes QA Managers/Officers, Qualified Persons, QC-,
Production-, Logistics Managers or Supervisors. Additionally, those who are indirectly involved in inspections may benefit from this training.

Learning goals

• Awareness of the approaches and differences between EU/WHO/FDA and client inspections and audits
• How to assemble the correct team(s) for hosting the inspection/audit and selecting the appropriate
  preparation strategy and prioritizing your efforts
• Identifying the do’s and don’ts during the inspection and applying them

Results

• Responding in a professional and timely manner to inspector/auditor requests, leaving a better
  impression and resulting into an efficient inspection/audit,
• Better insight into your GMP/GDP compliance status before and after inspections/audits,
• Involving the relevant people in your inspection preparation and hosting teams,
• Understanding the critical points to focus on as an organization.

Content

• Who is inspecting? – differences between
  EU/WHO/FDA and client inspections and audits
• Preparation – preparation team, gap identification,
  priorities, arranging your back office
• Preparing your personnel – how to behave during an audit
• The inspection day – basic behavioral rules, do’s and don’ts during receiving, tour, document check, wrap up
• Follow-up after inspection
• Action plan for your own organization