Live Online Training: Pharmaceutical Contracts - GMP and Legal Compliance
Course No 18560
All times mentioned are CET.
Costs
| ECA-Member: | EUR 1490,-- |
| Non ECA Member: | EUR 1690,-- |
| EU/GMP Inspectorates: | EUR 845,-- |
| APIC Member Discount: | EUR 1590,-- |
| QP Member Discount: | EUR 1490,-- |
(All prices excl. VAT)
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Carsten Coors, form. Vetter Pharma-Fertigung GmbH
Dr Rainer Gnibl, EU-GMP Inspector, Local Government
Dr Monika Hupfauf, Attorney-at-Law
Dr Rainer Gnibl, EU-GMP Inspector, Local Government
Dr Monika Hupfauf, Attorney-at-Law
Objectives
Three prerequisites are needed to work out contracts which are legally and GMP compliant:
- Awareness of the GMP requirements
- Applicable legal and juristic knowledge
- The practical perspective.
During this Live Online Training you will learn how to cover all these relevant aspects.
Background
Not only caused by increasing contract manufacturing and analysis, every pharmaceutical company establishes business connexions with a number of suppliers and service providers worldwide. The regulating authorities call for correctly defined, agreed and controlled contracted services. The EU-GMP Guide and international legislation require a written contract between the partners which clearly establishes the duties and responsibilities of each Party.
By compiling these contracts it is of extreme importance not only to meet the legal expectations. The company and the responsible persons need to be aware of their tasks and their liability. Not to mention that the contents should be easily transferable into the daily work and must be reduced to practice.
By compiling these contracts it is of extreme importance not only to meet the legal expectations. The company and the responsible persons need to be aware of their tasks and their liability. Not to mention that the contents should be easily transferable into the daily work and must be reduced to practice.
The speakers in this education course have substantial knowledge in the design and implementation of contracts in the pharmaceutical industry.
You will get first hand practical Information.
You will get first hand practical Information.
Target Group
This Live Online Training is designed for all personnel involved in the realisation of contracts. It also applies to decision makers and responsible persons who must implement the subject matters of the contract. The course is addressed to both the contract giver and the contract acceptor.
Technical Requirements
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
GMP Requirements and Expectations of the Regulatory Authority
- Outsourcing of activities
- Which external activities require Technical/ Quality Agreements?
- Regulatory requirements and legal basis
- How to create a Technical/ Quality Agreement
- Is a Quality Agreement essential for QP and QA?
International Law: Basic Juristic Knowledge for Responsible Functions
- International laws and systems – how they work and fit together
- Jurisdictions and conflict of law provisions
- Contract law
- Jurisdictions law
- General product liability concepts
- Case studies
Agreements – The Legal Perspective
- Confidentiality agreement
- Technical/ Quality Agreement
- Supply Agreement
- Other Agreements
- Their structure and how they fit together within the supply chain
Design and Layout of Contracts – Evaluation of the Content
- Basic principles – contractual obligations and responsibilities towards third parties
- Contents of agreements
- Definitions
- Timelines and Targets
- Loss of Products
- Intellectual Property
- Assignment
- Term and Termination
- Arbitration
- Practical examples
Pharmaceutical Contracts in the Light of Inspections
- Frequent findings
- Business contract vs. Technical/ Quality Agreement
- Table of content
- Clear responsibilities
- Product life cycle and Technical/ Quality Agreement
- Internal contracts
- Evaluation of a Technical Agreement (interactive session)
The GMP Technical Agreement/ Quality Agreement
- Who is involved
- Helpful terms and arrangements
- Demands and challenges
- Quality agreements during development
- Economic limits
The Delineation of Pharmaceutical Responsibilities and the Mutually Agreed Specifications
- Minimum content
- Who is involved?
- Helpful terms and arrangements
- Perception and supervision of agreed responsibilities
- Implementation of contractual obligations into company GMP System
Supply and Service Agreements: what you need to know
- Practical aspects you need to consider when establishing contracts with
- Suppliers of excipients and packaging materials
- Service providers (e.g. clothing, pest control)
Case Studies: Evaluation of Contract Examples and Cases
Question and Answer Sessions
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
Every participant will get various contract examples:
- Agreement on Contract Manufacturing of
- Medicinal Products
- Medical Devices
- Foodstuffs
- Contract Testing of Medicinal Products
- Agreement on Quality Assurance concerning
- Starting Materials
- Transport of Medicinal Products
Prepared by the German Medicines Manufacturers’ Association (BAH).
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity