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Workshop overview:

According to the FDA, injectable solutions have one of the highest degrees of concern associated with route of administration and a high likelihood of packaging dosage form interaction.  Consequently extractables and leachables need to be very carefully considered for prefilled syringes.

The workshop will cover the complete spectrum of extractables and leachables, focusing on:
o Regulatory guidance and recommendations
o When to start testing and how to set studies up
o Selecting materials to be used in a device
o Extractable and leachable testing including limits of detection needed
o Case studies
o Change management of materials

Key Benefits of Attending:

• Analyse current regulatory guidance and strategy management
• Share insight with experienced specialists in the fields of leachables and extractables
• Learn about relevant cases studies in analysis and selection
• Develop solutions to challenges in the field
 

 

Who should attend?

Chief Executives, Chief Scientific Officers, Vice Presidents, Heads, Directors, Principal Scientists and Managers in the following areas:

  • Business Development
  • Chemistry, Manufacturing, Controls
  • Commercial Operations
  • Contract Management and Partnering
  • Drug Delivery Systems
  • Drug Device Process Development
  • Drug Device Safety
  • Drug Product Process Development
  • Formulation & Aseptic Filling Technologies
  • Industrial Development
  • Labelling
  • Manufacturing
  • Novel Drug Delivery Systems
  • Packaging Development
  • Parenterals
  • Pharmaceutical Sciences
  • Product/Pharmaceutical Design & Development
  • Quality Assurance
  • Regulatory Affairs
  • Safe Medication Practice

 

The workshop will be led by Dr. Andrew Feilden.

Dr Andrew Feilden joined Smithers Rapra as a principal consultant in June 2011.  He is specialising in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications.  For the previous 12 years he was at AstraZeneca, leading their extractable and leachable testing.  He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years.  Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group.  Andrew gained a degree and D.Phil from York University.

Smithers Rapra, part of the Smithers Group of companies, has been recognized as a world leading rubber and plastics consultancy delivering a comprehensive and strictly independent service since its establishment over 90 years ago.  These services have been tailored to support the medical device and pharmaceutical industries where polymers are widely used.  Much of our work for this sector is in the field of Extractables and Leachables testing for drug delivery devices, immediate packaging and bioprocess equipment, however we are also able to support the development of medical and drug delivery devices and, where required, comprehensive failure diagnosis.  

 

 

 

Workshop programme

10:00 Registration & Coffee

10:30 Introduction and Welcome

10:45 Introduction to Extractables and Leachables

11:45 Morning Refreshments

12:05 Material Selection and carrying out controlled extraction studies

13:15 Networking Lunch

14:15 Extractable and leachable analysis including case studies

15:30 Afternoon Refreshments

15:45 Presentation on Industry working groups and managing change

16:45 Question and Answer Session

17:00 Close of Workshop

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Marriott Hotel Regents Park

128 King Henry’s Road
London NW3 3ST
United Kingdom

Marriott Hotel Regents Park

This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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