QP Module: Pharmaceutical Packaging

About this course

Despite advances in technology, quality problems with packaging still continue to occur. Print origination and packaging processes continue to be a major reason for product recall!

This module has been carefully designed to cover all important aspects of the packaging process, from selection of suitable components, pack design, packaging processes and their associated GMP challenges, through the supply chain to the patient.

The module aims to provide the necessary understanding of packaging materials and the packaging process to enable the Qualified Person to carry out his/her duties with knowledge and professionalism.

Equally, the module will be of value to staff involved in Packaging Development, Packing Operations, QA and QC.

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

Packaging Components

• Primary (contact) materials, their composition and properties
• Choosing the most appropriate material for specific applications
• Pre-treatment of components
• Requirements for receipt and testing
• Supplier considerations

Pack Design

• Contact packaging components
• Reducing the risk of mix-up
• Industrial codes of practice, e.g. PS 9000

The Packaging Process

• Packaging machinery – an overview
• Packaging operations – the GMP challenges
• Recalls – an overview
• In-process controls
• Automatic security and detection systems

Regulatory Aspects

• Stability testing requirements
• Labelling regulations
• Marketing Authorisation Application requirements for packaging components

The Route to the Patient

• Wholesale dealing – including a visit to a wholesaler
• Retail pharmacy visit

Concerns for the QP

• Counterfeits
• Controlled temperature storage and distribution

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.

Venue

Carlton President Utrecht Hotel, Utrecht, The Netherlands

The Carlton President Utrecht Hotel is centrally located near Maarssen, and offers spacious, luxurious hotel rooms for rest and relaxation.

Their conference room is equipped with all the necessary facilities plus offers 300 parking spaces – which makes it extremely convenient.

Hotel Accommodation

• 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

Carlton President Utrecht Hotel
Floraweg 25
3542 DX UTRECHT
The Netherlands

Tel: +31 (0)30 241 41 82

http://www.carlton.nl

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.

• 

  Dr Gary Rees
  Consultant
  BPharm, PhD, CChem, MRSC, FCQI, CQP

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

  Mrs Erika Notman
  Consultant
  BSc, MBA, CBiol FSB, MRSPH

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

What you've said

“Excellent course. Found the visits particularly beneficial as that provided good variation and offered ‘real’ examples of theory covered.”

Tristram Evans, Biotec Services International

“I thought this course was very good especially the organised visits during the week. The practical aspects of the course bought to life the theoretical - well done!!”

Anonymous

“Good mix of lectures, group sessions and industrial visits. The visits were an excellent opportunity to see how the theory of the course is put into practice in real industrial situations.”

Matt Young, Aptuit

“Visits were very informative and useful, to help understand the supply chain and issues and risks to consider as a QP.”

Phil Cryan, Piramal Healthcare