About this course
Manufacturing sterile products is easy – until things go wrong!
When things go wrong catastrophically, decision making is relatively straightforward.
However, things are rarely so ‘black and white’. The biggest challenge facing anyone in sterile products manufacture is to deal with the ‘grey area’ problems which arise almost daily and which require decisions which are…
- Scientifically justified
- Based on an objective and realistic assessment of RISK
- In compliance with regulatory requirements and expectations
- And GOOD for your business!
The objective of this course is to help you improve your problem solving and decision making skills when presented with any situation associated with the manufacture of Sterile Products. The skills you learn could save your company $millions in rejected product!
What You Will Learn
You will be given the skills and, through practice, the confidence to deal with any situation and make the right risk-based decision no matter how challenging the scenario. For example:
- High environmental counts in a Class A (viable and non viable)?
- Unexpectedly high pre-filtration bioburden counts?
- Momentary drop in temperature and pressure during autoclave cycle?
- Filling room occupancy higher than has been simulated during media fills?
- HEPA filter integrity test failure during requalification?
- Sterile filtration of solution takes longer than is permitted in the manufacturing instruction?
- Higher than normal reject rate during visual inspection?
- High microbial counts on hands of operator detected at exit monitoring?
- Unplanned deviation from approved steriliser loading pattern?
…and many more
This is not a ‘typical’ training course where someone lectures to you for days at a time. The majority of the course will be spent on tasks in small groups, ‘real life’ problems that many of you face each day.
- ‘Key Point’ lectures will provide you with the most up-to-date information, sufficient to promote informed and lively discussion
- You will then be given ‘real life’ problems to solve in small groups. Tutors will guide and facilitate discussions, encourage debate and provide you with model answers. You will learn from each other as well as from us
It is not what you know that matters. It is what you do with what you know that really matters.
Course outline
The Theory
Lectures will cover essential information on current EU and US requirements for…
- Cleanrooms and controlled environments
- Sterilisation processes
- Environmental monitoring (viable and non viable)
- Process simulations
- Container integrity testing and visual inspection
- Environmental monitoring
- Personnel monitoring
- Cleaning and sanitisation
As well as…
- Risk Management principles and the major risk assessment techniques: HACCP and FMEA
The Practice
You will be split into small ‘working groups’ and asked to take decisions on a range of scenario situations using the tools and techniques covered. A unique course providing you with a unique opportunity to improve your decision making skills.
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
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 shortly”
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 experts for this course are:
What you've said
“Course was very interesting and helpful!”
Ulrike Nettekoven, F Hoffmann-La Roche, Switzerland
“Tutors were really experienced and blessed with English humour. Four days of benchmarking ideas, procedures and so on. Was of high use as from the first hour. Interaction within the entire group was great.”
Hans Noordergraaf, Abbott Biologicals, The Netherlands
“I will be able to identify (focus) on key areas in auditing sterile facilities.”
Joanne Hiep, Adcock Ingram, Republic of South Africa
“A very valuable crash course in steriles that I am sure will stay with me for a long time.”
Mark Worgan, Aesica Queenborough, UK
“Complexity at right level. Confident and decisive tutors. Good intensity and pace. Particularly good buzz sessions.”
Peter Clark, SCM Pharma, UK
“This course came highly recommended. I was not disappointed!”
Odile Smith, Sanofi Pasteur, US
“The best course I’ve ever attended”
Randy Freidman, Genentech, US
“Course scenarios/buzz groups were excellent, and real life situations. Learned most from these.”
Kieran Fitzgerald, Shire Pharmaceuticals, Republic of Ireland
“The course tutors were outstanding”
Julia Stoll, Emergent Biosolutions, US
“Very enjoyable and very useful.”
Joanna Hodges, Reckitt Benckiser, UK
An NSF International Company 
