07 Oct, 2019 - 10 Oct, 2019

SEATS

80 People

SPEAKERS

16 Professionals

Hosted by

Title Sponsor

Cape Town, South Africa

PROGRAMME

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
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
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
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
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 -

Lunch

About this event

Under the auspices of the Working Group on Good Laboratory Practice, the 14th OECD Training Course for GLP Inspectors will be held in Cape Town, South Africa from 07 Oct,2019 – 10 Oct,2019. This course will be organized as a four – day advanced training course for GLP inspectors. The course will comprise lectures and discussions focusing on practical aspects of GLP inspections as well as parallel workshops on how to select studies for a study audit, auditing a GLP study/data integrity, test and reference items, non-compliance decisions and computerised systems.

The course is being hosted by South Africa’s GLP Compliance Monitoring Authority (South African National Accreditation System, SANAS). The course will be given in English by representatives of GLP compliance monitoring programmes from member countries and MAD adhering countries and will be based on the OECD GLP procedures for inspections.

More…

GUIDANCE DOCUMENTS FOR GLP AND COMPLIANCE MONITORING

Visitors to this page should go to box at the bottom of the page, entitled  “GUIDANCE DOCUMENTS FOR GLP AND COMPLIANCE MONITORING” for links to all of the relevant documents.

All documents can be downloaded for free.

Programme of 14th OECD Training Course for GLP Inspectors

The programme of 14th OECD Training Course for GLP Inspectors, to be held in Cape Town, from 07 Oct, 2019 – 10 Oct, 2019 can be found on the link below.

Cape Town Points of Interests

Brand SA Videos

speakers

Céline Dugué

Safety and Pharmacovigilance Inspection Unit ANSM (France)

Charles Bonapace

US Food and Drug Administration

Christoph Moor

Federal Office for the Environment (Switzerland)

Elizabeth Moane

National Association of Testing Authorities (Australia)

Fariza Wan Abdullah

Accreditation Division Department of Standards Malaysia

Guido Alphonse Jacobs

Scientific Institute of Public Health (Belgium)

Kenji Nakano

Pharmaceuticals and Medical Devices Agency (Japan)

Martin Reed

Medicines and Healthcare Products Regulatory Agency (UK)

contact us

Training Enquiries:

Shadrack Phophi – shadrackp@sanas.co.za
Tshenolo Molamu– tshenolo@sanas.co.za

Training Logistics Enquiries:
Azwi Radebe – 14glpoecd@cvpromos.co.za

South African National Accreditation System
+27 (0) 12 740-8400

ADDRESS

Libertas Office Park
cnr Libertas and Highway Street
Equestria
0184
South Africa

hosted by:

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