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Categories To Find "Pharmaceutical Good Manufacturing Practice" Experts:
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ANTITRUST |
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Antitrust or competition laws are laws which seek to promote economic and business competition by prohibiting anti-competitive behavior and unfair business practices. Government agencies known as competition regulators regulate antitrust laws, and may also be responsible for regulating related laws dealing with consumer protection.
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GMP - GOOD MANUFACTURING PRACTICES |
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Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs).
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the production and laboratory testing environment itself. An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product is considered contaminated (in the US considered adulterated).
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INTELLECTUAL PROPERTY - ANALYSIS |
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In law, intellectual property (IP) is a broad entitlement extending the concept of property beyond its materialist definitions to include information, ideas, and other intangible assets in their expressed form. Depending on jurisdiction, IP rights generally enable the holder to exercise exclusive rights over the the subject matter (or "work") of the IP using copyright, patent, trademark, industrial design right and similar legal protections. The term reinforces that such works are the product of the mind or intellect and that any rights may be protected at law in the same way as any other form of property.
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INTELLECTUAL PROPERTY - LICENSING |
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In law, intellectual property (IP) is a broad entitlement extending the concept of property beyond its materialist definitions to include information, ideas, and other intangible assets in their expressed form. Depending on jurisdiction, IP rights generally enable the holder to exercise exclusive rights over the the subject matter (or "work") of the IP using copyright, patent, trademark, industrial design right and similar legal protections. The term reinforces that such works are the product of the mind or intellect and that any rights may be protected at law in the same way as any other form of property.
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ISO 9000 |
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ISO 9000 is an ISO standard for Quality Management Systems.
ISO 9000 was developed from the British Standards Institution's BS 5750. The ISO 9000 standard is maintained by ISO (the International Organization for Standardization) and administered by accreditation and certification bodies. It is widely used in manufacturing, although high costs and difficulties with implementation have led to many companies using alternatives such as IC9700, or IC9200, both of which are issued by the International Charter, or their own specific in-house 'standard'.
Some countries re-label ISO 9000 as a national standard. (e.g. IR 9000 in Iran).
It should be emphasised that ISO 9000 does not guarantee the quality of the end products - rather, it certifies that the correct manufacturing process is being carried out.
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MERGERS / ACQUISITIONS |
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The phrase mergers and acquisitions or M&A refers to the aspect of corporate finance strategy and management dealing with the merging and acquiring of different companies as well as other assets. Usually mergers occur in a friendly setting where executives from the respective companies participate in a due diligence process to ensure a successful combination of all parts.
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PATENTS |
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A patent is a set of exclusive rights granted by a state to a person for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which is new, inventive, and useful or industrially applicable.
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QUALITY ASSURANCE |
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In engineering and manufacturing, quality control and quality engineering are involved in developing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. These systems are often developed in conjunction with other business and engineering disciplines using a cross-functional approach.
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Pharmaceutical Good Manufacturing Practice Experts Witnesses - Pharmaceutical Good Manufacturing Practice Forensic Consultants.
Find Pharmaceutical Good Manufacturing Practice experts and consultants for Pharmaceutical Good Manufacturing Practice litigation support. Available to be Pharmaceutical Good Manufacturing Practice expert witnesses and provide Pharmaceutical Good Manufacturing Practice forensic consulting in Pharmaceutical Good Manufacturing Practice litigation, in addition prepare Pharmaceutical Good Manufacturing Practice expert witness reports for use in deposition and/or in-court trial testimony.
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Pharmaceutical Good Manufacturing Practice
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