Qualified Person Education Course

Qualified Person Education Course

Berlin, Germany

Course No 17279


Costs

Regular Fee: EUR 1690,--
ECA-Member: EUR 1490,--
EU/GMP Inspectorates: EUR 845,--
QP Member Discount: EUR 1490,--

(All prices excl. VAT)

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

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, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium

Objectives

Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the EQPA Board of Directors, pharmaceutical industry and regulatory authority will share their experience on important issues of the QP’s 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
Workshop on Case studies:
Certification by a QP and Batch Release - to certify or not, that’s the Question
  • Batch release: degrees of freedom and limits
  • The QP’s discretion as defined in Annex 16
  • Case Studies
Experiences made with the MRA and post-Brexit
  • Inspections, GMP certificates, importation, acceptance of US CoAs…
  • What we have experienced
  • Problems occurred and solutions found
Workshop:
Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?

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 QP’s 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: 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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK