Control of cross-contamination is a major compliance issue in our industry today.
£1470.00 excl. VAT or £1764.00 incl. VAT
(2nd delegate bookings from the same company and same site will receive a 20% discount on the course fee)
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!
Current Regulatory Expectations
Using Risk Assessment to Set Priorities and Acceptance Criteria
- Manual procedures
- Automated systems
- Clean In Place (CIP)
- Clean Out of Place (COP)
- Holding times
- Selection of sampling sites
- Sampling methods
- swabs vs. rinse samples etc
- Creating a defendable cleaning matrix
- 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
- 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.
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.
- 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.
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
“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