Qualified Person Education Course Module A - Online Training Recording

Costs

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

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

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

Speakers

Julia Gudd, GMP and GDP Inspector, Ministry of Justice and Consumer Protection, Hamburg, Germany
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
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 roles 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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

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

Case Studies: Certification by a QP and Batch Release (to certify or not)

Batch certification: degrees of freedom and limits
Batch deviations and QP Certification
Examples: To certify or not, that’s the question

Case Study: 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

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

What the QP needs to know about Pharmacopoeias

The world of different Pharmacopoeias
Pharmacopoeias are more than just Monographs
How to deal with different methods

Case Studies: 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

Recording from 29/30 November 2023
Duration of the recording: approx. 11.5 hours

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