About this course
The way a company responds to Out of Specification (OOS) results is a key part of GCLP, which first came to prominence in 1993, following the Barr case. The US FDA first issued draft Guidance for Industry on handling OOS results in 1998.
In October 2006 the final version of the FDA OOS Guidance was published. In late 2010, the UK MHRA published the first Guidance on this subject by a European authority. This course will compare the US and UK guidance.
The adequacy of the investigations that should take place following the generation of an OOS result, and the release/reject decision that must subsequently be made, is seen as a key measure of the overall integrity and probity of a pharmaceutical company.
This course is designed to provide you with practical advice on how to investigate OOS results and make appropriate decisions, which will meet regulatory expectations and add real value to your business.
The recent quality system guidance, such as ICH Q10 and the FDA Process Validation, means that inspectors are now focusing much more on trend analysis.
Every company will inevitably generate OOS and Out of Trend (OOT) results at some time, so this is an area of GMP compliance that cannot be ignored.
What You Will Learn
- The Barr Case history
- What the October 2006 FDA OOS Guidance says and what it means
- What the 2010 MHRA Guidance says and what it means
- How to assess the quality of the data generated by your laboratory
- The relationships between OOS, OOT and other atypical results
- How to identify OOT stability results
- How to conduct effective OOS and OOT investigations and interpret the results
- What to consider when making batch release decisions
Course outline
OOS and OOT results
- The Barr Case
- FDA’s October 2006 Guidance for Industry and 2010 MHRA guideline on OOS results:
- Scope
- Laboratory investigations
- ‘Full-scale’ investigations
- Re-testing and re-sampling
- Reporting of results
- Concluding investigations
Assessing the quality of laboratory data; identifying OOT and atypical results
Practical guidance on conducting laboratory investigations
The making of batch release decisions following OOS and OOT investigations
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work,where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Glen Hove Conferencing, Johannesburg, South Africa
Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.
For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]
The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]
Catering
During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements
If you have any special dietary requirements, please contact the conference management.
Venue Address and Contact Details
Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196
PO Box 2467, Houghton, 2041
Tel: 011 442-3601
Fax: 011 442-3678
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
-
Dr Allan Thomas
Partner
Dip.Pharm, MPharm, DPharm, MPS(SA), MPD(IMD), CHE(NWU)
What you've said
“Very helpful! Good explanation and overview of all related topics.”
Ken Fergusson, Smith & Nephew, UK
“Good interactive style of passing information. Sufficient detail on the course notes. Good balance between information and time allowed.”
Mahboob Rehman, Intertek ASG, UK
“Excellent course – very informative. Thank you!”
Steven Craythorne, Caridian BCT, UK
“Always useful and interesting the interactive sections (Teamwork).”
Claudio Piazza, Chiesi Farmaceutici, Italy
“Excellent clarification of a so complex topic.”
Thomas Wendling, Celgene International, Switzerland
An NSF International Company
