New EU GDP Guidelines: What is expected, where to start, and what tools are available to help?

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This FREE webinar was recorded on:
June 19, 2013
10:00 AM - 11:00 AM EST

On March 8, 2013 the final version of the new EU GDP Guidelines was published by the Pharmaceutical Committee of the European Commission. Not since 1994 has the European pharmaceutical industry seen such sweeping changes.  The new guidelines support an industry convergence to combat counterfeiting, leverage new technologies and guarantee patient safety. Join our webinar to learn the details – what is expected of all players in the supply chain around quality management, risk assessment and maintaining control.

Key Takeaways –

  • In-depth review of the new EU GDP Guidelines:  which products are included, who must comply, what is expected of all parties.
  • How to develop a fully documented quality management system.
  • Implications for temperature controlled transportation.
  • What tools are available in the market to provide assistance and support.
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Presenters:

Richard Peck
Senior Program Manager
Sensitech Inc.

Richard has worked in the Life Sciences industry for over a decade.  He is currently a Senior Program Manager in the Professional Services division of Sensitech, Inc., serving customers in the EMEA region.  Working as a Thermal Compliance and Process Improvement Specialist, his role is to assist customers in maintaining an efficient and robust Cold Chain Management Program whilst staying compliant to both national and international GDP regulations.

Richard gained an honours degree in Mechanical Engineering before starting his career with GlaxoSmithKline. He moved in to the Cold Chain industry as the head of the Cold Chain Technology team at Wyeth Pharmaceutical’s EMEA Cold Chain Centre of Excellence in the UK.  His responsibilities included the management of the Good Cold Chain Management Practices both on site in the UK and to affiliates globally.  Prior to Senstiech, he was the Global Head of Technical Services and Quality at Softbox Systems Limited, a leading global manufacturer of temperature controlled passive shipping systems.

Richard is an active member of the PDA’s Pharmaceutical Cold Chain Interest Group where he sits on the European Steering Committee.  He has contributed to numerous technical reports including the recently published TR58 – Risk Management for Temperature-Controlled Distribution and the Active Temperature Control Systems: Qualification Guidance to be published in early 2013.  He also resides on the International Air Transport Association’s (IATA) Time and Temperature Task Force.

Olivier Simonnot
Strategic Market Manager, Life Sciences EMEA
Sensitech Inc
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Sponsored By:
Sensitech