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YOUR PRESCRIPTION FOR USP <232> <233> and ICH Q3D COMPLIANCE Regulations for Elemental Impurities

Lunch & Learn

Wednesday April 19 – 2017 at Waterfront Congress Centre in Stockholm

Please join us for lunch and let us help you become compliant


To help your company prepare for one of the most significant changes in pharmaceutical regulatory policy in over a century, think PerkinElmer & L.A.B. Analytical Nordic!

As an undisputed leader in Environmental and Human Health Science, PerkinElmer has the proven technology, expertise and validation services your laboratory operations need to become fully compliant with the new ICH Q3D and USP 232/233 requirements. When it comes to elemental analysis, your company cannot find a stronger partner than PerkinElmer.

This event will provide you with guidance on how to support your organization in providing data to demonstrate compliance with the new regulatory limits for elemental impurities in pharmaceutical products.

It will provide an overview of the finalized USP and ICH requirements and give details about how to successfully set up and validate appropriate methods before the deadlines set by the different regulatory bodies.

In addition it will provide an introduction to the PerkinElmer Validation Toolkit and Instrumentation and how these will ensure your method validation is compliant with the new USP chapters and other global regulatory requirements.


Agenda-setting

10:30 Registration and Refreshments - Coffee / tea / buns

11:00 Introduction (LAB Analytical)

11:20 USP232, ICH Q3D, EP & JP - regulations / permissible levels (Jon Sims)

11:50 Elemental impurities instrumentation (David Price)

12:10 Lunch & Mingling

13:00 Risk assessments and requirements (Jon Sims)

13:30 PerkinElmer USP232 Validation Tools (Jon Sims)

13:50 Enhanced security software and CSV (Jon Sims)

14:10 Discussion and questions

14:30 Close

 Rest of the day

The speakers are available for individual meetings


Early bird registration before March 19; 1300 SEK/attendee excl. VAT.

Registration post March 20; 1500 SEK/attendee excl. VAT.

The price includes Swedish fika, lunch and presentations material and an opportunity to meet with an USP- and application specialist for ICP-MS.

Cancellation post March 19 will be charged with 500 SEK excl. VAT.


SPEAKERS:

PerkinElmer is pleased to announce that Jonathan Sims, a career chemist and recognized expert in trace metals analysis, has been retained by the company as Technical Advisor to enhance and support comprehensive solutions for the new USP (U.S. Pharmacopeia) regulations.

Jon is a recently retired analytical manager from pharmaceutical giant GlaxoSmithKline, where he helped develop and implement strategies for ICH (International Conference on Harmonisation) Q3D, USP , and pioneered automation and the use of Inductively Coupled Plasma Spectrometry.

Jon's expertise in the area of USP risk assessment and the relationship between pharmaceutical and contract analytical service labs will be instrumental with implementation of the new regulations. In addition, Jon’s extensive experience in the GMP (Good Manufacturing Practices) environment will be a valuable resource to PerkinElmer’s Validations Team.

Jon holds a BSc (Honours) in Chemistry from Loughborough University. He is also a member of the Royal Society of Chemistry, Association for Laboratory Automation, and acts as a referee for the Journal of Pharmaceutical Sciences.

David Price has 20 years of ICP-MS experience and joined PerkinElmer in 2012 from Anglian Water where he was the Metals Laboratory Manager. His work with Anglian Water involved team management, technical support, validation of new instrumentation and adherence to quality regulations.

Previous roles have been R&D or laboratory service related in the UK, Australia, USA and France. Since joining PerkinElmer David has developed a wealth of experience optimising customer protocols for a variety of challenging elements and matrices.

His role covers on and off site customer support, customer training and new method development.


L.A.B. Analytical Nordic AB
Fryksdalsbacken 34, 123 43 Farsta
Telefon: 08-29 60 29
e-post: info@labanalytical.se, order: order@labanalytical.se 

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