Live Online: Impurities Workshop Part III - Elemental Impurities
Im Auftrag der ECA Academy

Live Online: Impurities Workshop Part III - Elemental Impurities Im Auftrag der ECA Academy

Seminar Nr. 18618

All times mentioned are CET

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Ulrich Rose, EDQM, France
Jürgen Martin, Martin-Consulting, Germany
Dr Andrew Teasdale, AstraZeneca, UK

Zielsetzung

In Part III of the Impurities Workshop the key principles of the ICH Q3D Guideline on elemental impurities will be highlighted. You will get to know the essential aspects and approaches of how to assess the risks and control elemental impurities in drug substances, drug products and excipients.

You will learn
  •  what has to be considered with respect to the drug substance monographs of the European Pharmacopoeia,
  •  how to perform a risk assessment in order to establish a control strategy for elemental impurities,
  •  how the route of administration and the duration of exposure affect the limits of elemental impurities,
  •  which potential sources of Elemental Impurities within the supply chain you have to be aware of.

Hintergrund

In November 2014 the ICH Q3D Guideline for Elemental Impurities was published as Step 4 document. This document outlines
  •  the evaluation of the toxicity data for potential elemental impurities
  •  the PDEs for each element of toxicological concern
  •  the basis for an EI risk assessment and the key factors for evaluation.
  •  the development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE
Meanwhile ICH Q3D was revised twice, regarding Cadmium Inhalation PDE (ICH Q3D(R1); Step 2 document) and cutaneous and transdermal products (ICH Q3D(R2); Concept Paper)

Zielgruppe

The Live Online Training addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.

Technical Requirements

For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Part III: Elemental Impurities on 03 December

European Pharmacopoeia Activities (Policy) on Elemental Impurities – an Update
  •  Implementation of Q3D in Ph. Eur.
  •  Changes in individual and general monographs
  •  Harmonisation of general chapter 2.4.20
  •  Second phase for revision of excipient monographs
Risk-Based Approach for Elemental Impurities in the Supply Chain
  •  APIs, excipients, packaging materials impacting the purity profile
  •  Evaluation of supply chain processes
  •  Risk analysis as evaluation tool
  •  Audits and monitoring programs as important sources
  •  Testing strategies
Control Strategies for Elemental Impurities in Final Dosage Forms – Case Studies
  •  Utilisation of Data as part of an Integrated EI Risk Assessment Process
  •  Potential Sources of Elemental Impurities in the Finished Product
    • API
    • Equipment
    • Container-closure system
    • Excipients
  •  Conclusions
Workshop:
Conducting a Risk Assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.

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