Quality Management Systems
With the ever changing demands of the regulatory environment it is easy to lose sight of how complex our quality systems become over time. We are able to offer a service to evaluate the effectiveness of your quality system using Quality Risk Management as a methodology for justifying any changes. If you reduce complexity of your QMS, you will reduce the risk of errors and reduce your costs.
Quality Assurance (QA) and Quality Control (QC)
We have several years of experience of working within both Quality Assurance and Quality Control, which allows us to take a pragmatic approach to our consultancy. We can either offer advice and guidance or simply help you with planning the development of QA and QC department.
We can also provide advice and guidance about how to successfully integrate quality into your organisation and how to ensure that the quality groups add value to an organisation instead of simply being viewed as a cost. We are also able to offer Analytical method development and validation services along with training.
We can also offer Laboratory Qualifications. For more information, please visit our qualifications page.
Human Error
Is the term “operator error” a common identified root cause?
Human Error helps us to understand why that individual made that error in the first place. We can help organisations by providing an understanding of Human error, helping you get to the real root cause and eliminate them in the future. Human Error training is the start of the journey and we can help you plan the implementation, provide coaching and help you integrate it with your existing systems and processes. In the GxP environment, Human error is often used in conjunction with your deviation and CAPA systems and will lead to more effective overall error management.
We have recently delivered our Human Error course to the MHRA.
Qualifications and support
Want to offer nationally recognized qualifications for your people?
If so, we can help. NVQs and Technical Certificates are part of the vocational framework, some of which are included within the various new Trailblazer apprenticeship frameworks. We are able to help you to set up to offer these qualifications in your own company and either leave you to manage the qualifications yourself or we can do that for you. Some of these qualifications may attract funding and we can offer these through our alliance partnership with New College Swindon. Please contact us to find out more.
For more information please visit our qualifications page.
Auditing
Want to take away the burden of auditing?
We can help by auditing your suppliers on your behalf as well as providing advice and guidance. If you have recently had some regulatory findings, following a regulatory audit we can help you in terms of analysing the real issues and providing potential solutions to close those actions. We have a very experienced QP and auditors as part of our team, who have all spent time in both investigational medicines and manufacturing environments. We can also offer coaching to trainee QPs, particularly in preparing for their viva.
Organisational Development and change Management
Developing organisations in almost every case involves an element of change. We have a great deal of experience in this field and no development/change project is too small.
Many organisations focus on skills and knowledge development but behavioural change has proven to make a significant difference to many organisations. The team has a huge amount of experience in this field and can help with
- viral change programmes
- behavioural change programmes
- role profiling and performance management
- Competency based recruitment
Our consultants have experience of working with people at all levels of an organization as well as experience of working in both HR and technical roles
Lean and six sigma
In this highly competitive world it is now more important than ever to try and reduce costs to the business. We can help by offering support in the use of improvement techniques. We can help with developing a strategy for introducing a “continuous improvement culture” into your organization which can range from just using a few simple tools and techniques, lean sigma through to yellow belt and green belt.
Our consultants have extensive experience in leading and managing lean and six sigma projects.
Human Error and behaviours
Whilst it is vitally important that your people have the right skills and knowledge to enable them to do fulfill their roles, behaviours make a significant difference to how they perform their role.
We are the leading experts in behavioural Good Pharmaceutical Practices (bGxP) as well as Human Error.