QP Module 3a: Formulation and Processing Part 1

About this course

Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.

This module addresses the two important activities of formulation and processing and provides key information on…

• How the physico-chemical attributes of the drug and the therapeutic indication influence:
  • route of administration
  • dosage form
• Assuring bioavailability
• Methods of manufacture of oral dosage forms
• Factors affecting suitability for use of the major dosage forms

The Qualified Person, and other key technical personnel, MUST have a detailed understanding of these topics if they are to…

• Assist in the design and implementation of relevant, effective, quality systems for dosage form manufacture
• Contribute to the RISK ASSESSMENT process for processing changes and unplanned deviations
• Assess the adequacy of cleaning strategies
• Assess the potential impact of changes to physical and chemical attributes of starting materials

This, therefore, represents one of the key modules in this series.

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

Formulation Issues

• Molecular properties of drugs and how these can influence metabolism, stability and biotransformation
• Pharmacokinetics
• Bioavailability
• Bioequivalence

Oral Dosage Forms – Tablets, Capsules, Liquids

• Major processing methods for solid dose, liquids and semi-solids
• Formulation challenges for the oral route of administration
• Critical process steps
• Key GMP requirements
• What goes wrong and the role of the QP

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, 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

www.hilton.com

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 - link to be confirmed shortly”

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:

• Simon Mackay, University of Strathclyde, UK
• Gavin Halbert, University of Strathclyde, UK
• James Johnson, University of Strathclyde, UK
• Alastair Davidson, University of Strathclyde, UK

• 

  Mr Mike Halliday
  Executive Director
  BSc (Pharm), MRPharmS, PGDip

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

What you've said

“QP scenarios very good and useful.”

Robert Scott, Cancer Research UK, UK

“Very good module that ties very well with module 2 for a better understanding of the purpose of the Pharmaceutical Industry.”

Nuno Furtado, Baxter Healthcare, UK

“Tutors were excellent and interesting.”

Philip Rose, Patheon UK, UK

“Very good course, complex principles explained well and concisely.”

Jonathan Dormer, UCB Pharma, UK

“A hard subject made easy to understand.”

Nigel Chesterton, Bio Products Laboratory, UK