Qualified Person Education Course

(Im Auftrag der European QP Association)

Programm

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 need 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, that’s the Question

• Batch release: degrees of freedom and limits
• The QP’s 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?

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

• Understanding the scope of your outsourced activities: More than Contract Laboratories and CMOs
• Communications and relationships with your outsourced partners: Product Quality Review, Quality Risk Management, Knowledge Management
• Selection, approval and ongoing oversight of outsourced partners: When to get involved,
• How much oversight is enough – taking a risk based approach to oversight, Metrics and KPIs
• Contracts – Development, Maintenance and ensuring adherence: 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

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.