course programme
Day 1 Wednesday 12th September 2012
8.50 Registration
9.00 Welcome and Course Objectives
9.15 Basics and Background
10.00 Regulations
10.45 Break
11.00 FDA Preparation for Inspections
11.45 Inspection Support Strategy
12.30 Lunch
13.15 Workshop Discussion
13.45 Inspection Preparation (on receipt of notification)
14.45 Break
15.00 Inspection Conduct (during the inspection)
Sponsor/CRO
16.00 Interview Techniques
16.45 Panel Discussion, Review of the Day and Wrap-up
17.30 Close of day
Day 2 Thursday 13th September
9.00 Interview Practice Workshop
10.15 Inspection Close-out Meeting
10.45 Corrective and Preventive Action (CAPA)
11.15 Break
11.30 Inspection Report
12.15 Formulation of Responses
13.00 Lunch
13.45 Response Exercise
14.15 Sustained Inspection Readiness
15.00 Break
15.15 Inspection Close-out, Follow-up of CAPA
15.45 Course Review and Follow-up
16.00 Close of course
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, EMEA, 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 the rest of the world
10.00 Regulations
- Standards the inspections are conducted against i.e. FDA CFRs, EU Directives, National regulations, ICH E6.
10.45 Break
11.00 FDA Preparation for Inspections
11.45 Inspection Support Strategy
- Level of QA support for inspections
- Contract Research Organisation (CRO)/sponsor/investigator site
- Accountability and responsibility at sponsor, CRO and site
12.30 Lunch
13.15 Workshop Discussion
- Brainstorming session on strategies for inspection preparation, including specific challenges that may arise. Delegates are encouraged to raise topics of interest.
13.45 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
- Select studies ‘ripe’ for the inspection and likely sites
- Logistics – book rooms, photocopier, etc.
- Communication with potential sites and support in preparation
14.45 Break
15.00 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
- Document review
- Staff interviews
- Tour of facilities
- Pharmacy
- End of day summary
- from inspectors
- De-briefing of site staff
16.00 Interview Techniques
- Presentation on interview techniques.
16.45 Panel Discussion, Review of the Day and Wrap-up
17.30 Close of day
Day 2 Thursday 13th September
9.00 Interview Practice Workshop
- Role-play, small groups (4 or 5 – inspector, interviewee, scribe, QA) – sponsor/CRO and investigator sites.
10.15 Inspection Close-out Meeting
- Determine up-front who should attend, who should document the observations, strategy for requesting clarifications.
10.45 Corrective and Preventive Action (CAPA)
- Developments and Lessons Learnt
- Convene task force to do this following the exit meeting.
11.15 Break
11.30 Inspection Report
- Receipt of report
- Communication
- Examples of findings
- Definitions of severity used by inspectorates
- Consequences of inspections findings – especially if critical
12.15 Formulation of Responses
- How to respond
- Formulating responses – examples of good/bad
- What to do if you disagree with an observation
- Managing inspectors’ expectations
13.00 Lunch
13.45 Response Exercise
14.15 Sustained Inspection Readiness
- Quality management system
- Documented inspection process
- inspection training
- Organisational documents
- Contracts and agreements
- Inspection and audit findings
- Quality awareness and GCP training
15.00 Break
15.15 Inspection Close-out, Follow-up of CAPA
15.45 Course Review and Follow-up
16.00 Close of course