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 The US FDA first issued draft Guidance for Industry on handling OOS results in 1998.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 pharmaceutical training 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 pharmaceutical training 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 Guidance 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.
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.
This course is 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.
Venue
Manchester Marriott Victoria and 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 a few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- 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.
Venue Address and Contact Details
Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England
Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link”: link to be confirmed at a later date
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
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:
What you've said
“Great information and advice/guidance especially since we are in the beginning of implementing.”
Olivia Fitzgerald, Servier (Ireland) Industries, Republic of Ireland
“Very good course – met perfectly my requirements.”
Sebastien Robert, Servier (Ireland) Industries, Republic of Ireland
“An excellent overview.”
Neil Stewart, Allergan Europe, UK
“I found the section on statistical analysis particularly helpful as this is an area I was less experienced in.”
Louise Sterritt, Fleet Laboratories, UK
“Excellent resource for knowledge and explanation of terminology and regulations.”
Tracey Price, AstraZeneca, UK
“Very interesting and useful. Thanks for answering my questions. I will take back what I have learned and put it into practice. I certainly have some answers for my audit tomorrow.”
Kay Armstrong, Reckitt Benckiser Healthcare, UK
“It was a good interactive course. Especially liked the information/explanation about the trend analysis and how to identify them in an early stage.”
Vera van Mourik, TEVA Pharmaceutie, The Netherlands
“It gave me a very good overall picture of OOS/OOT investigations from a QP viewpoint and also very useful pointers for auditing contractors. Thank you very much.”
Mary Hendrick, Labopharm Europe, Republic of Ireland
“Particularly enjoyed the examples and practical exercises.”
John Boulby, Thornton & Ross, UK
“It’s opened my eyes that there is a lot more (especially statistics wise) to OOS results.”
Paul Armitage, Thornton & Ross, UK
“Thank you about this lecture, it covers all the topics we needed.”
Sameera Al-Khteeb, Saudi Food and Drug Authority, Saudi Arabia
“I benefited from this course because it answered my questions about OOS and OOT and also about the control chart.”
Sanaa Ali El-Sammani, Food and Drug Authority, South Arabia.
“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
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