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Course No 16686

Qualified Person Education Course - Understand the Implications of Working as a QP

21-22 March 2019, Prague, Czech Republic


Costs:
Non-EQPA/Non-ECA Members: EUR 1.690,--
EQPA/ECA Members: EUR 1.490,--
EU GMP Inspectorates: EUR 845,--
(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers


Dr Ulrich Kissel, European QP Association

Savvas Koulouridas, Fagron BV, The Netherlands

Aidan Madden, FivePharma, Ireland

Sue Mann, Sue Mann Consultancy, U.K.

Rico Schulze, GMP Inspectorate, Local Authorities Dresden, Germany

Lance Smallshaw, UCB, Belgium



Learning Objectives


Broaden and intensify your knowledge of the Qualified Persons duties and responsibilities. Experts from the QP Association Advisory Board, pharmaceutical industry and regulatory authority will share their experience on important issues of the QPs daily business and will give first-hand information on current and future expectations.


Background


Over the last years the role and responsibilities of the Qualified Persons have been increasing considerably. As a key person in the company, the QP has to consider many issues and has to take up the challenges within its areas of responsibilities. Additionally, as laid out in Article 49 of the European Directive 2001/83/EC, the QP needs to be highly qualified and experienced. This education course is one important part to help the QP be on top of current developments in GMP and regulatory requirements.

Target Group


New and future Qualified Persons, QPs who are looking for ongoing training and personnel who want to get a detailed overview of the role and responsibilities of a QP.

Programme


The Legal and Professional Duties of the Qualified Person
  • The Qualified Person within the EU legislation and regulation framework
  • Professional tasks, duties and responsibilities
  • Expectations of an EU GMP Inspector
Update on European Requirements
  • EU GMP Guide Chapters
  • EU GMP Guide Annexes
  • Other important News
  • What the QP needs to be aware of
Delegation of Duties and Responsibilities
  • Possible scenarios according to Annex 16
  • Mutual Recognition Agreements (MRA)
  • Documentation review issues
  • The QP in the quality system
What the QP needs to know about Elemental Impurities
  • What guidance is available
  • What does it mean for the QP
  • From Risk Analysis to Batch Certification and Release
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
  • The QP: ultimate responsibility for the supply-chain of a drug product?
  • What is the expected scope of supply chain oversight
  • Supply chain integrity
  • Active Pharmaceutical Ingredient, Excipients, Bulk and Finished Product
  • Shipping under quarantine, ship to label claim, importation testing
  • The role of the QP in supplier qualification and auditing
  • Written confirmation and QP Declaration
  • GMP meets GDP: where does the responsibility end?
  • The QPs involvement in the recall process
  • How the QP fits into the Quality Systems
    How much involvement is needed in systems like:
    • Product Quality Review
    • Inspection Management
    • Batch Record Review
    • CAPA
    • Change Control
    • Validation
    • Complaints and recalls
    • Batch certification and release
    • Laboratory investigations
    Liability and indemnification
    • Liability and indemnification of QPs
    • Role and responsibility of head of production and head of quality control (when things go wrong)
    • Role and responsibility of upper management (when things go wrong)
    • Delimitation of responsibilities with QPs in the same company
    • Delimitation of responsibilities with QPs at a contractor
    Workshop on Case studies: Certification by a QP and Batch Release - to certify or not, thats the Question
    • Batch release: degrees of freedom and limits
    • The QPs discretion as defined in Annex 16
    • Case Studies
    Workshop:
    Deviations during the Manufacture of an API What Actions should you take as the responsible QP?


    Workshop: What the QP needs to know about OOS/OOT
    • Involvement of the QP
    • Role and responsibility of the Head of Quality Control
    • Responsibility of the QP

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