Practical Implementation of Quality by Design: Regulatory Submissions

About this course

Although the pharmaceutical industry is now investing more heavily in Process Analytical Technology (PAT) and some companies are working towards implementation of Quality by Design (QbD) principles in their manufacturing processes, there is only limited guidance from the main regulatory agencies about how information, in support of this, should be provided within a submission.

This course looks at the regulatory implications and practicalities of preparing the Quality Section of a CTD file to introduce QbD concepts into new and existing submissions.

What You Will Learn

• The principles behind QbD/PAT and its origins in both the EU and USA and the development of the ICH Guidelines
• How to include PAT and QbD information into your regulatory dossier
• The impact of QbD on change management of regulatory approvals
• The advantages and disadvantages of incorporating PAT/QbD principles into a regulatory file

Course outline

• What is QbD?
• The strategy for QbD
• Current regulatory expectations for QbD
• How to build QbD into a regulatory submission
• Lifecycle management

Discussions and Working Groups

A significant proportion of 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

Hilton York Hotel, York, UK

The Hilton York Hotel is conveniently located in the city centre and boasts 130 high-quality rooms, two popular restaurants and secure parking. The historic city of York has many attractions for visitors; the famous Minster, many museums, the Jorvik Viking Centre and excellent shopping. London is two hours away by train and there is a direct rail link to Manchester Airport. Leeds/Bradford Airport is also nearby.

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 will be provided to you on receipt of a completed booking form.
• 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

Hilton York Hotel
1 Tower Street
York
YO1 9WD
England

Tel: +44 (0)1904 648 111

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 expert for this course is:

• 

  Mr Bruce Davis
  Consultant
  BEng, CEng, MICE

  • [email protected]
  • +44(0)1751 432999

What you've said

Testimonials for this course will be available at the end of November 2012 since this a new course for 2012