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
To Be Confirmed
The venue for this course will be confirmed at a later date.
Venue Address and Contact Details
To Be Confirmed
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:
To be confirmed at a later date
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
