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GCP Regulatory Inspections - Tools and Skills for Successful Preparation, Hosting and Responding to Inspections

Course Information

This course has been designed to provide you with the necessary skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection findings. The course encompasses inspections at sponsor and contract research organisation sites, as well as at the investigator site. The course will also look at current inspection finding trends, and inspection hot topics/focus trends.

Benefits include

  • A clear understanding of the regulatory inspection process
  • Practical experience of preparing for and hosting inspections
  • Techniques for interpreting findings and observations and facilitating the preparation of effective responses
  • Techniques for facilitating correction, corrective and preventive action arising from inspection findings

Webcast

The tutors have recorded an introductory webcast - click here to view.

Course Tutors

Bruce Seymour-Taylor
Director, Seymour-Taylor Consulting Ltd (Course Principal)

Monjit Summy
Director, Saffron Pharma Consulting Ltd

Recent Feedback

"The tutors were knowledgeable and engaging"

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Accommodation

Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Course Programme

Day 1

8.50 Registration
9.00 Welcome and Course Objectives
9.15 Basics and Background
* Introduction and background of GCP inspections in the major regions: EU, EMA, FDA, MHLW, MHRA (and other EU MS)
* How active are the various national inspectorates
* Where do the different regulatory authorities inspect e.g. FDA in US and ROW
10.00 Regulations
Standards the inspections are conducted against i.e. FDA CFRs, EU Directives, National regulations, ICH E6
10.30 Break
10.45 Inspection Support Strategy
* Level of QA support for inspections
* CRO/Sponsor/investigator site
* Accountability and responsibility at sponsor, CRO and site
11.45 Open Discussion
Brain-storming session on what areas can be included as part of inspection readiness for sponsors, CROs and sites.
12.30 Lunch
13.30 Inspection Preparation Workshop
14.45 Inspection Preparation (on Receipt of Notification)
* Convene an inspection team
* Communications within the company
* Defining roles and responsibilities of team members
* Inspection training – what does this look like
* Preparation and submission of requested documents e.g. GCP Dossier
* Select studies `ripe' for the inspection and likely sites
* Logistics – book rooms, photocopier, etc.
* Communication with potential sites and support in preparation
15.30 Break
15.45 Inspection Conduct (During the Inspection) Sponsor/CRO
* Arrival – Preparing security and reception personnel
* Document management/logging /control/copying
* Document review
* Dealing with multiple inspectors
* Check agenda, document request for the next day
* End of day summary from the inspectors
* Challenging findings and obtaining clarification
* End of day summary to company management
* Investigator Site
* Document review
* Staff interviews
* Tour of facilities
* Pharmacy
* End of day summary from inspectors
* De-briefing of site staff
16.45 Wrap-up and Close of day

Day 2

9.00 Interview Techniques
Presentation on interview techniques.
9.15 Interview Practice Workshop
Role-play, small groups (4 or 5 – inspector, interviewee, scribe, QA) Sponsor/CRO and
investigator sites.
10.30 Inspection Close-out Meeting
Determine up-front who should attend, who should document the observations, strategy for requesting clarifications.
11.00 Break
11.15 Corrective and Preventive Action (CAPA) Developments and Lessons Learnt
Convene task force to do this following the exit meeting
11.45 Inspection Report
* Receipt of report
* Communication
* Examples of findings
* Definitions of severity used by inspectorates
* Consequences of inspections findings – especially if critical
12.30 Lunch
13.30 Formulation of Responses
* How to respond
* Formulating responses – examples of good/bad
* What to do if you disagree with an observation
* Managing inspectors' expectations
14.00 Sustained Inspection Readiness
* SOP covering inspections
* Functional representation
* Sponsor and CRO communication – importance of consistency
* What needs to be done at site?
* Re-inspection – filing of evidence for issue resolution
14.00 Break
15.00 Inspection Close-out, Follow-up of CAPA
15.30 Course Review and Follow-up
15.45 Close of course

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