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 The US FDA first issued draft Guidance for Industry on handling OOS results in 1998.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
The course will begin at 09.00 and finish at 16.00
Best Practice for the Analytical Laboratory
The integrity of analytical laboratory data relies on the knowledge, understanding and training of all the people involved
Over the past 25 years NSF-DBA has built a strong reputation for providing high quality training on numerous aspects of Good Manufacturing Practice. We are pleased to be able to offer you a suite of three linked courses covering current best quality practices for chemical analytical laboratories.
- Analytical Methods: Documentation, Validation and Transfer
- Investigating Out of Specification Results
- Ongoing Stability Testing
This suite of courses is designed to cover a range of inter-related topics covering best quality practices within chemical analytical laboratories.
These courses are designed to provide you with our ‘trademark’ practical advice on what to do to achieve cost-effective quality assurance whilst satisfying current regulatory authority expectations.
Those of you who are new or less experienced will benefit from the whole suite. We will provide you with the knowledge and practical interpretation you need to perform your duties.
Those of you with greater experience or who are changing roles may wish to focus your participation so we enable you to select which modules to attend.
Each of the related courses will explore the detailed aspects of the topics that cause you concern and we are available at all times to answer your specific questions. Attendance will enable you to network with other delegates and benchmark your laboratory’s performance.
Venue
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks
of the River Irwell, near the city centre but convenient for Manchester
Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and the Living Well Health Club with pool, gymnasium, sauna and steam room is just a few
minutes from the hotel.
Also nearby are the Imperial War Museum North West, Lowry Museum and Manchester’s three theatres. A few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- We have a block booking of bedrooms at the Manchester
Marriott Victoria & Albert, at a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions
(issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel.
If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain
your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
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 experts for this course are:
Chris Burgess
Dr Burgess also has 35 years’ experience in the pharmaceutical industry primarily with Glaxo in Quality Control, Quality Assurance and Analytical R&D. Dr Burgess has published over 70 papers and books in analytical science. He is a member the PDA (USA) Scientific Advisory Board on OOS Task Force and presented at the PDA/FDA meeting of the new OOS Guidance in December 2006 in Washington DC.
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
