GMP Workshop: Supply Chain Assurance & Anti-Counterfeiting

About this course

Over recent years the pharmaceutical industry has moved to more global strategies for R&D, manufacturing and sourcing of its ingredients. The growth of outsourcing, often to countries with less mature pharmaceutical industry understanding and regulatory systems, has also been significant as companies seek to lower their costs of operating.
In parallel, significant public health issues have occurred related to the supply chain of excipients (e.g. Glycerol), APIs (e.g. Heparin) and counterfeiting of finished medicinal products. The response from the European Commission and FDA has been to propose new legislation to mitigate the risks.
This course will cover the proposals from the regulators, the responses from the pharmaceutical industry, its suppliers of excipients and APIs, and related associations, along with good industry practices for ‘end to end’ supply chain assurance.

What You Will Learn

• FDA initiatives and views on supply chain assurance
• EU initiatives and views on supply chain assurance
• What has gone wrong – case study
• Views and proposals from excipient and API suppliers
• Examples of industry practices for supply chain assurance
• Key steps to combat the counterfeiter
• The risks to the company, the industry, the patient

Course outline

Current and developing regulatory expectations including:

• EU
  • Proposed amendments to EU legislation
  • APIs
  • Excipients
  • Counterfeiting
  • API Inspection cooperation pilot
  • Distribution chain
• USA
  • FDA Globalisation Act
  • Good Importer practices
  • Secure supply chain pilot

Case studies of what has gone wrong

• Heparin
• Glycerol
• Gentamycin

Views of ingredient suppliers/other groups

• IPEC – excipients
• APIC – APIs
• Certification schemes

Industry Practices for Supplier Assurance

• Supplier Assurance programmes
• Quality Risk Management
• Quality Agreements
• Packaging Technologies

Opportunities for industry and regulators to work together

Venue

Manchester Marriott Victoria & Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks
of the River Irwell, near the city centre but convenient for Manchester
Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and the Living Well Health Club with pool, gymnasium, sauna and steam room is just a few
minutes from the hotel.

Also nearby are the Imperial War Museum North West, Lowry Museum and Manchester’s three theatres. A few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• We have a block booking of bedrooms at the Manchester
  Marriott Victoria & Albert, at a specially negotiated bed and breakfast rate per delegate per night.
• As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions
  (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. 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.

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:

• 

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

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

  Mr Graham Clapperton
  Consultant
  BSc (Hons) Industrial Chemistry & Management Studies; FRSC; MCQI; EurChem

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

What you've said

‘Very enjoyable course.’

Claire Richer, GlaxoSmithKline, UK

‘The fact that we can contact tutors for specific questions is very helpful in terms of day to day activities.’

Rachid Kouri, GlaxoSmithKline Biologicals, Belgium

‘Very beneficial to me! It has given me a wider understanding of other areas within the industry. It has allowed me to remove my blinkers and look at the bigger picture.’

Nicola Spencer, Dales Pharmaceuticals, UK

‘Great informative course. Enjoyed the buzz groups and the group interactions.’

Regina Dempsey, Shire Pharmaceutical Ltd, UK