About this course
We all know that the quality of your products depends on the quality of your people and the effectiveness of your Quality Management System (QMS). In fact, as Qualified Persons (QPs) and quality professionals, you can’t release product and stay in business unless your QMS is ‘in control’. This is easier said than done. Supply chains are more complex than ever before and you are being asked to do more with less, and faster! It is not surprising that failures in QMS are a key reason for severe regulatory action in Europe and the USA.
This course will provide you with answers to some really tough questions.
What You Will Learn
- How to meet the ever increasing demands of global regulatory agencies, both now and in the future
- How to succeed when others have failed and implement ICH Q10 (Pharmaceutical Quality Systems) successfully throughout the product lifecycle
- Contractors and third parties – how to manage quality across your supply chain, no matter how complex
- How to simplify every aspect of your QMS to reduce bureaucracy and improve speed and flexibility
- How the best in class manage quality to improve their competitive edge and improve regulatory compliance
Why This Training Will Benefit YOU
The Aspiring Qualified Person
- This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
- All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
- Our training is generally considered as the best available and our QPs are held in high regard within the industry.
- As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
- You are more likely to become a QP with us than with any other training provider!
The Pharmaceutical Technical Professional
- Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
- Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
- Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
- This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at [email protected] for more information
Course outline
- Understanding regulatory trends and requirements (EU and FDA)
- ICH Q8, 9 and 10: how to implement and maintain across the product lifecycle
- How to manage quality at suppliers and third parties and maintain ‘quality oversight’
- The essential elements of an effective and simple documentation system
- Validation: the ‘modern paradigm’
- Deviation reporting systems that drive continuous improvement
- Simple and effective change management (yes, it is possible!)
- Complaints and recall procedures that work
- Technical agreements: management of third parties
- Good distribution practices and cold chain management
- Audit and self-inspection: designing and implementing sensitive and reliable programmes
- The role of senior management and the ‘quality professional’
- Risk management and risk-based decision making
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 question and concerns.
This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at [email protected] for more information.
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre and its many attractions. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
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
York Marriott Hotel
Tadcaster Road
York
YO24 1QQ
England
Tel: +44 (0) 1904 701 000
Fax: +44 (0) 1904 702 308
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
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
“A very good course, really useful for me. Special thanks to the tutors – enthusiasts! Very competent. Good training in terms of organisation between reading/buzz groups/breaks – good rhythm.”
Laurence Robert, Baxter Bioscience Manufacturing, Switzerland
“A highly and professional way in how the course material was delivered mixing theory and practice thus making it more easy to remember and understand.”
Emmanuel Cassar, Actavis, Malta
“It has been a really interesting week. I obtained several good ideas that I expect to implement now and later in my company. The approach for continuous improvement is a concept essential for the future.”
Javier Castañeira, MSD Animal Health, Spain
“I am highly benefited from the QP9 module as it has given me the whole picture of a QMS of a company. Also realisation of the fact that it is a ‘Business Management System’ and not only quality. Also the course helped me to understand the practical implementation of ICH Q10.”
Sayantani Nath, APC Pharmaceuticals & Chemicals, UK
“The bar has been raised again. Yet another module that has exceeded my expectations.”
Anthony Merckel, Reckitt Benckiser Healthcare, UK
“One of the best courses I have done so far. I gained a lot of knowledge on how to create, implement and maintain a QMS. A very good interactive course.”
Leen Van de Water, Pannoc, Belgium.
“A great course, with really informative team works. Particularly liked the ‘bridge’ diagram of the PQS”
Matthew Scarff, Rosemount Pharmaceuticals, UK
“Learned a lot. Lots of interaction - great teachers very experienced/enthusiastic. I will try and come back for more modules! Thank you a lot.”
Margaret van der Maij, Erasmus Medical Centre, The Netherlands
“The course more than met my requirements of learning about QMS and what is coming in the future. It was well structured and has given me a lot of food for thought and motivation to improve my business and myself”
Adam Haigh, Perrigo, UK
“Course well delivered by passionate presenters. Good to get best industry practices from experienced people. Good to get MHRA insight”
Peter Griffiths, Patheon, UK
“Excellent - knowledgeable lecturers, as always. Inspired strategic thinking and broadened my perspective”
Barbara Glantschnig, Octapharma Pharmazeutika, Austria
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