Sprecher
Richard Bonner, Chairman of the EQPA, formerly with Eli Lilly, UK
Sue Mann, Sue Mann Consultancy, UK
Ann McGee, McGee Pharma International, form. Senior Inspector of the Irish Medicines Board (now HPRA)
Dr Bernd Renger, Immediate Past Chair of the EQPA
Rico Schulze, GMP Inspectorate, Germany
Lance Smallshaw, UCB Pharma, Belgium
Zielsetzung
Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the QP Association Advisory Board, 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.
Hintergrund
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 Parliament 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.
Programm
The Legal and Professional Duties of the Qualified Person
The Qualified Person within the EU legislation and regulation framework
Different European authorities (e.g. EU Commission, DG Enterprise, EMEA, EDQM)
Professional tasks, duties and responsibilities
Interface and delimitation to the QPPV (Qualified Person for Pharmacovigilance)
Update on European Requirements
EU GMP Guide Chapters
EU GMP Guide Annexes
Other important News
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 regarding the Supply Chain(from Supplier Qualification to GDP)
The QP: ultimate responsibility for the supply-chain of a drug product?
The role of the QP in supplier qualification and auditing
Written confirmation and QP Declaration
GMP meets GDP: where does the responsibility end?
Storage
Distribution
Cold chain management
The QP’s involvement in the recall process
Outsourcing: what the QP should know about assuring Product Quality
Co-operation with contract laboratories and TPMs
Contracts: Supply, Quality and Development Agreements
QP’s roles and responsibilities: audits, complaints, adverse events, change control
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
Case Studies
Certification by a QP and Batch Release – to certify or not, that’s the Question
EU Regulations
Annex 16
The QP’s Discretion
Case Studies
Workshop:
Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
Parallel Sessions:
1) What the QP needs to know about Laboratory Operations to ensure correct Decision Making
Responsibilities
OOS, OOT and OOE results
Failure Investigation
Method validations
2) What the QP needs to know about Investigational Medicinal Products (IMPs)
EU GMP and QP requirements for the release of
Investigational Medicinal Products
GMP-GCP Interface
QP oversight and being a QP in a global environment
Liability of the IMP QP
Case studies
You will be able to attend one of these parallel sessions. Please choose the one you like to attend when you register for the Course.
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E-Mail: info@concept-heidelberg.de
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