Resolution Analytical Consultancy
Training provided by Resolution
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Best Practices in Bioanalytical Method Validation
Training
Best Practices in Analysis
Resolution is able to offer a variety of training options centered around the extending the knowledge base of anyone involved in dealing with Analytical data, allowing you to maximise the potential of your staff.  Course attendees have included Programme Managers, Toxicologists, Clinicians, CRAs and Quality Assurance staff wishing to gain a better understanding of the contribution analytcial data makes to drug development programmes (for example, Basics of Analytical Chemistry Today) in addition to Analytical Chemists needing specific training (for example, Best Practices in Bioanalytical Method Validation).  All aspects of the science can be covered and the emphasis is on flexibility, tailoring each course to meet your requirements and expectations.
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Key Benefits
Comprehensive and relevant
Tailored to your requirements
Reduces companies internal training burden
 
Capabilities

Resolution
can visit your site to undertake any laboratory based training you require.  Desk-based courses can be conducted at your site, in Edinburgh or at a venue of your choice.  A selection of courses is detailed below, but please do not hesitate to ask if you require training that is not listed.

Best Practices in Bioanalytical Method Validation

A properly executed method validation is essential to ensure the validity of all subsequent data generated using that method.  The US FDA’s “Guidance for Industry Document” (May 2001) defines validation standards and expectations which are accepted by all major regulatory agencies worldwide.  Understanding these guidelines should ensure Bioanalytical staff generate acceptable data in support of international pre-clinical and clinical drug development programmes.  This course aims to train staff to interpret and implement the FDA guidelines to ensure international regulatory compliance for bioanalytical data, and includes the latest topics from the Agency debated at the AAPS 3rd Bioanalytical Workshop, Crystal City, May 2006 and the most recent meeting on Incurred Sample Reproducibility, Crystal City, February 2008.  It is suitable for analytical staff involved in any kind of Bioanalytical work in support of Drug Development or for QA staff with responsibility for auditing such data.

Outsourcing & Managing Analytical Programmes

Analytical Chemists and Project Managers are sometimes faced with limitations in resources and/or skills within their organisations that could limit the rate of progress on the project.  Outsourcing to Contract Research Organisations may be a solution, but can bring it’s own unique challenges.  This course aims to train staff to successfully outsource and manage analytical programmes and is aimed at Chemists and Mangers with responsibilities in this area.  Topics include when to consider outsourcing, considerations in selecting a laboratory, defining requirements and expectations, negotiating payment schedules, managing problems, monitoring and communication.

Best Practices in Analytical Chemistry

This course is aimed at ensuring your analytical processes are being performed as well as they should be.  Topics covered include “Do”s and “Don’t”s of every key aspect in the practice of analytical chemistry to ensure the generation of reliable accurate data and to minimise repeat work.  It is suited for trainee scientists or analytical scientists looking for refresher training.
The Basics of Analytical Chemistry Today
Analytical Chemistry is a specialised science that plays an increasingly key role in many development or regulatory programmes.  Consequently, the technologies now in routine use may not be readily understood by Programme Managers, Toxicologists, Clinicians, CRAs or Quality Assurance staff who nonetheless have to work with the data coming out of the laboratory.  Understanding what, why and how Analytical Chemists do what they do will provide an insight into how to avoid many of the problems that can hamper this critical aspect of drug development and improve everyone's understanding of the entire process.This course aims to explain, in plain English, the technologies, processes, terminologies and strategies in use by today’s analytical chemists and is suitable for anyone using analytical data who wants to learn more about it.
Tailored courses
If there is a training need related to laboratories or Analytical Sciences that is not covered by any of the above, please contact Resolution to discuss if it is possible to meet your needs.


 
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Analytical Chemistry for Programme Managers, Toxicologists, Clinicians, QA and tailored courses