Cleaning Validation & Contamination Control
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Control of cross-contamination is a major compliance issue in our industry today.
Tuesday 12 to Wednesday 13 June 2025
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
£1360.00 excl. VAT – £1632.00 incl. VAT (first booking)
£1088.00 excl. VAT – £1306.00 incl. VAT (additional bookings from same site)
Type: Pharmaceutical
About this course
Control of cross-contamination is a major compliance issue in our industry today. Central to any effective strategy for control is the demonstration that our cleaning procedures are robust and capable of consistently removing residual products down to levels which do not pose a risk to patient safety.
Validation of cleaning procedures is thus critical to any Quality Assurance programme and is currently a topic of great concern to regulators worldwide.
This course has been designed to provide practical advice on how to design and execute cleaning validation studies to meet current regulatory expectations in a cost-effective way.
General principles of cleaning validation will be supplemented by specific case studies from industry specialists from…
- Dosage form manufacture and packing
- Active pharmaceutical ingredient manufacture
- Biopharmaceuticals manufacture
The special challenges of clinical trials manufacture and packing will also be covered in detail.
What You Will Learn
- Current international regulatory expectations for cleaning validation studies
- How to use risk assessment to…
- set validation priorities
- devise a scientifically sound cleaning matrix
- How to devise cleaning validation protocols which meet regulatory expectations and help you to gain the maximum amount of information from the minimum amount of work
- What to do when things go wrong!
Course outline
Current Regulatory Expectations
Using Risk Assessment to Set Priorities and Acceptance Criteria
Cleaning Procedures
- Manual procedures
- Automated systems
- Clean In Place (CIP)
- Clean Out of Place (COP)
Study Design
- Holding times
- Selection of sampling sites
- Sampling methods
- swabs vs. rinse samples etc
- Creating a defendable cleaning matrix
Analytical Methods
- Specific vs. non-specific methods
- Method selection
- Method validation requirements
Setting Acceptance Limits
- Current industry norms
- Different approaches
- dosage form manufacture
- API manufacture
- biotech applications
Change Control and Ongoing Monitoring
- Ensuring continuing effectiveness
- What to do when things go wrong!
Industry Case Studies
- Biotechnology
- Active pharmaceutical ingredients
- Dosage form manufacture
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 & 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:
Mark King, Actavis, UK
Mark has many years’ practical experience of validating cleaning studies for dosage form manufacture, especially tablets and capsules
Dave Sherwood, UCB, UK
Dave is an acknowledged expert on cleaning validation for biotechnology processes and has published widely on the subject
Nigel Goode, Aptuit, UK
Nigel has many years’ experience of validating cleaning procedures in the API industry.
What you've said
“The course was very useful and well-balanced, containing some fundamental information, up-to-date trends and case studies. Those parts which were less relevant to me were still interesting and could be useful in future for generation of ideas.”
Andrew Newman, Vectura, UK
“Good information – confirmed many of my prejudices, but provided guidance to progress CV implementation and improves cleaning record.”
Gregor McNeil, Vectura, UK
An NSF International Company
