16:00
16:00 -
Registration
Registration will begin on Sunday, 6 October, 2019 at 16h00 and end by 09h00 on Monday, 7 October, 2019.
17:00
17:00 -
Steering Group Meeting
Steering Group Meeting
19:00
19:00 -
Cocktail Reception
A welcome cocktail reception sponsored by SANAS will be hosted at Lagoon Beach Hotel on 6 October 2019 from 19h00
08:00
08:00 - 09:00 AM
Registration
Registration will begin on Sunday, 6 October, 2019 at 16h00 and end by 09h00 on Monday, 7 October, 2019.
09:00
09:00 - 09:30 AM
Welcome and Opening Remarks
RSA, OECD Secretariat & WG Chair
09:30
09:30 - 10:00 AM
GLP in International Context
Richard Sigman (OECD Secretariat)
10:00
10:00 - 10:30 AM
Overview of OECD GLP documents
Shadrack Phophi (RSA)
10:30
10:30 - 11:00 AM
Tea/Coffee Break
11:00
11:00 - 11:30 AM
Introduction to inspection process
Martin Reed (UK)
11:30
11:30 - 12:00 PM
How to select studies for a study audit
Elizabeth Moane (Australia)
12:00
12:00 - 12:30 PM
Auditing a GLP Study (including multi-studies)
Christoph Moor (Switzerland)
12:30
12:30 - 13:10 PM
Data Integrity (including electronic data)
Charles Bonapace (US - FDA)
13:10
13:10 - 14:00 PM
Lunch Break
14:00
14:00 - 15:00 PM
Workshop I
Facilitators: Marek, Charles, Christoph, Lize, Celine, Martin
- How to select studies for a study audit
- Auditing a GLP study /Data integrity
- Auditing a GLP study /Data integrity
15:00
15:00 -
Tea/Coffee Break
15:30
15:30 - 16:30 PM
Workshop I
- How to select studies for a study audit
- Auditing a GLP study /Data integrity
- Auditing a GLP study /Data integrity
16:30
16:30 -
Discussion on Workshop I
17:30
17:30 -
Q & A Session
08:30
08:30 - 09:00 AM
Inspection of Test and Reference Items
Fariza Wan Abdullah (Malaysia)
09:00
09:00 - 09:30 AM
How to understand new requirements in document No 19
Kenji Nakano (Japan)
09:30
09:30 - 10:10 AM
Non-compliance process: Making noncompliance decision and typical examples of noncompliance decisions
Guido Jacobs (Belgium)
10:10
10:10 - 10:40 AM
Tea/Coffee Break
10:40
10:40 -
Workshop II
- Test and refence items
- Non-compliance decision
- Non-compliance decision
13:10
13:10 -
Lunch
13:30
13:30 -
Sightseeing
19:00
19:00 -
Welcoming Dinner
08:30
08:30 - 09:30 AM
Discussion on Workshop II
Feedback presentation by Groups
09:30
09:30 - 10:00 AM
IT systems in the test facility
Lene Bjerring Bork (Denmark)
10:00
10:00 - 10:30 AM
Inspecting the computerized system
Martjin Baeten (Belgium)
10:30
10:30 - 11:00 AM
Tea/Coffee
11:00
11:00 - 11:50 AM
IT validation & Electronic archiving
Ronald Bauer (Austria)
11:50
11:50 - 12:20 PM
Commercial/outsourced archiving
Paula Korhola (Finland)
12:30
12:30 -
Lunch
13:30
13:30 -
Workshop III – Computerised system
Facilitators: Lene, Martjin, Ronald, Paula, Christoph
16:00
16:00 -
Tea/Coffee Break
16:30
16:30 -
Discussion on workshop III
17:30
17:30 -
Q & A Session
08:30
08:30 - 09:30 AM
The Receiving Authorities
R Jaspers (The Netherlands)
- role and responsibilities
- cooperation with Receiving Authorities
- role and responsibilities
- cooperation with Receiving Authorities
09:30
09:30 - 10:00 AM
Claiming compliance with principles of GLP
Celine Dugué (France)
10:00
10:00 - 10:30 AM
Tea/Coffee Break
10:30
10:30 - 11:00 AM
Risk-based quality assurance programme
Martin Reed (UK)
11:00
11:00 - 12:00 PM
Q & A Session
12:00
12:00 - 13:00 PM
Course Evaluation /Closing remarks/Certificate Handover
Shadrack Phophi (SA)
Richard Sigma (OECD)
13:00
13:00 -
End of Training
13:00
13:00 -