Dr Susanne Ding, Boehringer Ingelheim, Germany
Dr Ulrich Kissel, European QP Association
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, GMP Inspectorate, Local Authorities Dresden, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Dr Jurgen van Turnhout, Pelfort Pharma Consultant B.V, The Netherlands
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.
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.
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.
The Legal and Professional Duties of the Qualified Person
Update on European Requirements
- The Qualified Person within the EU legislation and regulation framework
- Professional tasks, duties and responsibilities
- Expectations of an EU GMP Inspector
Delegation of Duties and Responsibilities
- EU GMP Guide Chapters
- EU GMP Guide Annexes
- Other important News
- What the QP needs to be aware of
What the QP needs to know about Elemental Impurities
- 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)
- What guidance is available
- What does it mean for the QP
- From Risk Analysis to Batch Certification and Release
Outsourcing: what the QP should know about assuring Product Quality
- The QP: ultimate responsibility for the supply-chain of a drug product?
- What is the expected scope of supply chain oversight
- IMP vs. Commercial products
- 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
- 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:
Workshop on Case studies: Certification by a QP and Batch Release - to certify or not, that’s the Question
- Product Quality Review
- Inspection Management
- Batch Record Review
- Change Control
- Complaints and recalls
- Batch certification and release
- Laboratory investigations
- 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?
Workshop: What the QP needs to know about OOS/OOT
Pre-course Session: Investigational Medicinal Products (IMP)
- Involvement of the QP
- Role and responsibility of the Head of Quality Control
- Responsibility of the QP
QP Education Course on 21 February 2018
This pre-course session provides a detailed overview of the specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical trials.
The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore take into account these particularities and the GMP/GCP interface.
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Specific legal requirements for IMPs
- Different clinical phases I to IV, focus on patient safety
- Undefined processes (manufacture, fit for purpose control strategy, etc.)
- Why use risk assessments & how to apply – vital core
- of a IMP quality system
- Diversity: IMP manufacturers, start-ups, academia…
GMP meets clinical trials – Differences between IMPs and commercial Products
- Clinical Trial Regulation EU No. 536/2014 and the “old” Annex 13 and Directives 2001/20/EC and 2003/94/C
- The “new” ATMP regulation
Packaging & labeling
- Blinding / placebos
- NIMPs / AMPs
- Where to apply validation activities
- The Product Specification File (PSF)
- 3rd country manufacture of IMPs: import and the QP Declaration
GMP meets GCP
- IMPD, CTA, IND etc.
- Regulatory compliance and the two step release procedure
- Interaction with clinical sites