The QP in Switzerland - Online Training Recording
Costs
| Regular Fee*: | EUR 1490,-- |
| QP Member Discount*: | EUR 1390,-- |
(All prices excl. VAT). Important notes on sales tax.
* 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
Dr Ina Bach, Dr Bach AG, form. RHI
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG Lawyers
Karin Hofstetter, CSL Behring AG
Dr Ulrich Kissel, European QP Association
Dr Tillmann Lindenblatt, Fisher Clinical Services
Dr Carsten Meininghaus, DSM
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG Lawyers
Karin Hofstetter, CSL Behring AG
Dr Ulrich Kissel, European QP Association
Dr Tillmann Lindenblatt, Fisher Clinical Services
Dr Carsten Meininghaus, DSM
Objectives
- Learn and discuss the special tasks and responsibilities of the Responsible Person (RP) in Switzerland (Qualified Person/ QP according EU legislation).
- Exchange opinions and convey possible solutions to problems addressed in case studies and workshops.
- Benefit from the speakers’ experience in industry, authority and legal advice.
Background
Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EU-GMP regulation. This means that the GMP requirements of Directive 2001/83 / EC (in particular Article 46. to 52 for the QP) also apply in Switzerland.
The requirements for a Responsible Person (“Fachtechnisch Verantwortliche Person” in the German speaking part) are described in art. 5, art. 10, art. 14 and art. 15 of the Ordinance on Establishment Licences. With its signature, the RP confirms that a batch meets the specifications and has been manufactured in a GMP-compliant system. This system-related statement is considerably more comprehensive than a batch-related confirmation, which aims solely to comply with the specifications. Therefore the duties and responsibilities can be rather extensive.
In January 2019, the revised Therapeutic Products Act (HMG 2) and amendments to the ordinances (Therapeutic Products Ordinance Package IV) came into force - with some interesting alterations.
The requirements for a Responsible Person (“Fachtechnisch Verantwortliche Person” in the German speaking part) are described in art. 5, art. 10, art. 14 and art. 15 of the Ordinance on Establishment Licences. With its signature, the RP confirms that a batch meets the specifications and has been manufactured in a GMP-compliant system. This system-related statement is considerably more comprehensive than a batch-related confirmation, which aims solely to comply with the specifications. Therefore the duties and responsibilities can be rather extensive.
In January 2019, the revised Therapeutic Products Act (HMG 2) and amendments to the ordinances (Therapeutic Products Ordinance Package IV) came into force - with some interesting alterations.
Target Group
Responsible Persons/ RPs for batch certification and release and Executives and Managers who want to get an overview on the duties and responsibilities of the RP.
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.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
EU Regulations and their Implementation in Switzerland
- Directive 2001/83/EG and the Qualified Person
- Mutual Recognition Agreement
- Ordinance on Establishment Licences OEL (AMBV, OAMéd)
Role and Tasks of the Responsible Person
- The role in the company and the organisation chart
- Batch certification and release
- Cross-boarder activities
- Personal duties and responsibilities
- Delegation
- Deputies
- Internal delimitation of responsibilities
- Contract RPs
Examples: Certification and Batch Release
- To certify or not, that’s the question
- Decision making process
The GMP/GDP Interface
- Consequences of the Therapeutic Products Act and amendments to Ordinances
- Storage and transport
- Import and export: particularities
- Cool and cold chain issues
- Supply chain traceability
Outsourcing: What the RP should know about assuring Product Quality
- Compliance with the registration
- Compliance with GMP
- Audits and supplier qualification
- Necessary batch documentation
- Product Quality Review (PQR)
- Delimitation of Responsibilities in the supply chain
- Quality (Technical) Agreement
The API Supply Chain
- Requirements in Switzerland and the EU
- Responsibilities of the RP
- Questions, challenges and solutions
The Responsible Person’s daily Work: what the RP need to know about:
- Communication and collaboration with the authorities
- Risk Management
- KPIs
- Management Review
Liability
- Principles of liability
- When will the RP be liable?
- Potential sanctions
- Examples from the real life, case law
Examples: Quality Control and Laboratory
- What the RP needs to know
- Responsibilities
- OOS, OOE und OOT
- Fault analysis
- Statistics
Recording from 03.06.2020
Duration of the recording: approx. 8 hours
Duration of the recording: approx. 8 hours
Online Training & Webinar Recordings by topic
- Quality Assurance
- Biotechnology/Blood/ATMP
- General Microbiology Topics
- Regulatory Affairs
- Development
- Quality Control
- GDP - Storage/Distribution/Transportation
- Sterile Manufacturing
- Computer Validation
- General Validation/Qualification Topics
- General Engineering Topics
- APIs/Excipients
- General Manufacturing Topics
- Medical Devices and Combination Products
- GMP Basic Training Courses
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- OOS / OOT / OOE
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Hygiene
- Technology (Water Systems/Barrier Systems/Cleanrooms)
- Others