Sprecher
Richard M. Bonner, EQPA
Sue Mann, Sue Mann Consultancy, U.K.
Dr Bernd Renger, EQPA
Rico Schulze, GMP Inspectorate, Local Authorities Dresden, Germany
Lance Smallshaw, UCB, Belgium
Dr Jurgen van Turnhout, Pelfort Pharma Consultant B.V, The Netherlands
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
- Professional tasks, duties and responsibilities
- Expectations of an EU GMP Inspector)
- EU GMP Guide Chapters
- EU GMP Guide Annexes
- Other important News
- What the QP need to be aware of
- Possible scenarios according to Annex 16
- Mutual Recognition Agreements (MRA)
- Documentation review issues
- The QP in the quality system
- Batch release: degrees of freedom and limits
- The QP’s discretion as defined in Annex 16
- Case Studies
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
- 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 much involvement is needed in systems like:
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
- 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
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