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Compliance, the key to national health and business success
Compliance, the key to national health and business success
GlobalCompliancePanel (GCP) is a complete compliance knowledge source. Based in Wilmington, DE, it delivers a multi-structured, broad range of high quality regulatory and compliance-related solutions. These solutions are offered in a variety of ways.
Wilmington,
DE,
United States of America
(prbd.net)
14/03/2012
Rules and regulations govern every aspect of American life. All departments and industries, ranging from hospitals to nuclear power plants and schools to commercial complexes have to be in compliance of laws set out by the Federal government. Noncompliance is a very serious matter, as it can lead to disasters. So, what is compliance, and why does anyone need to comply?
One of the most commonly accepted definitions of compliance is this: “Compliance is either a state of being in accordance with established guidelines, specifications, or legislation or the process of becoming so”.
The importance of compliance in the medical industry: If there is one factor on which the US healthcare system revolves, it has to be compliance in the medical industry. Compliance is critical because even a slight deviation can play havoc on the lives of people. Compliance by various bodies, companies, healthcare providers and finally patients is indispensable to the success of the national health.
The costs and consequences of patient noncompliance are enormous. It is estimated that insufficient administration of treatment leads to at least 340 patient deaths every single day in the US. Noncompliance at least triples doctor visits to patients. The most telling piece of statistics is that noncompliance in the medical industry costs the US economy at least $100 billion!
Why compliance?
Why does the American healthcare and medical industry need to be in compliance? For the simple fact that such national disasters as mentioned above need to be prevented and eliminated. When a pharmaceutical company is in compliance with FDA rules and regulations, then the patient is assured good care and has improved chances of recovery. An FDA-compliant and FDA-noncompliant surgical device could easily be the difference between life and death of the patient.
Likewise, compliance is also very important for pharmaceutical companies. When they are in compliance, they are said to be supplying the right medicines and healthcare to patients, meaning that they are ethical companies. Ethical companies that are in compliance in FDA regulations are those that earn a good name in the industry and raise their stocks. They are seen as providers of the right services and products to patients, meaning that they are stakeholders in the national health policy.
Given the enormous importance compliance has for people in their day-to-day life and for businesses in the medical and healthcare industries, it is essential to implement compliance guidelines. How do companies do this? This is where the services of entities such as GlobalCompliancePanel matter.
GlobalCompliancePanel is a provider of trainings relating to compliance. It offers compliance trainings in a number of important areas. It seeks to contribute to the national health by making more segments of the medical industry be better equipped with compliance regulations.
About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a complete compliance knowledge source. Based in Wilmington, DE, it delivers a multi-structured, broad range of high quality regulatory and compliance-related solutions. These solutions are offered in a variety of ways.
Online Trainings: GCP brings compliance training from well-known compliance training Experts right into the participants’ location through live or recorded webinars. GCP does this through user friendly, cost effective mediums.
Some of the areas in which GCP offers specialized training include:
• Medical Devices
• Pharmaceutical
• Food
• PCI industries
• SOX.
Seminars: GCP also conducts live seminars at which Experts present their knowledge to participants from the industry in live interaction. The seminars, ranging from one to three days’ duration, are a great learning experience and an opportunity for participants to network with peers in the industry and with the Experts as well. The seminars also assist participants with certificates, credits etc. GCP has thus far conducted four highly successful seminars in India, at which three Experts have imparted their expertise on topics ranging from Validation of Methods and Processes to Validation and Part 11 Compliance of Computer Systems to Guidance on FDA Regulatory Requirements for Indian Pharmaceutical Industry. It will conduct such seminars across the globe soon.
Customized Consulting: Another of GCP’s principal offerings is high-specialty professional consulting. The Consulting arm of GCP is headed by the world-renowned Expert on Compliance, Dr. Steven Kuwahara, Founder & Principal, GXP Biotechnology, LLC. Dr. Kuwahara, who holds degrees in Biochemistry from Cornell and the University of Wisconsin, is an experienced analytical biochemist who has applied his knowledge to the quality control of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in relation to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and nutritional supplements.
The aim of this consulting service is to bring well-known Experts to offer customized consulting solutions to individual companies on a range of areas of concern to their business. GCP’s consultants have overseen the compliance requirements of dozens of companies on critical areas such as ISO and FDA. They have implemented a high number of quality management projects and systems. Some of the areas in which GCP’s Experts offer consulting:
• 21 CFR Part 11
• Analytical Development and Formulation, Drug Process Development
• Audit Preparation
• Bio analytical method development
• Bioresearch
• Clinical Research / Drug-Device Development
• Clinical trial
• Contract Manufacturing Compliance
• FDA Audit & Inspection
• FDA quality system
• Food Safety
• GCP compliance
• Global Regulatory Submission
• Immunogenicity and Bioassay Method Development
• IND, IDE, CAPA, GMP/cGMP Compliance & PMA’s
• ISO 13485/EN46000 and ISO 9000
• Laboratory Testing
• Lean Manufacturing
• Manufacturing, Packaging and Labeling
• Microbial control in Clean rooms and other critical environments
• Microbiology and sterilization
• Operational risk management, risk frameworks
• OSHA and MSHA litigation
• Pre-marketing to Post-marketing
• QMS Process & Maintenance
• Quality and process development
• Quality Systems and Laboratory Controls
• Risk Management
• Software Validation/Verification
• Supply chain development and management
• Toxicology
• Water systems, sterilization, aseptic processing
Customized Training Programs: GlobalCompliancePanel specializes in offering courses that are tailored to the participant’s exact and specific needs. These regulatory and quality compliance training programs are customized in a number of ways to enable participants to have a variety of choices with which they can get the best out of these trainings. GCP’s customization relates to:
• Level of training
• Duration of participant’s trainings
• Date and time of participant’s choice
• Expert of participant’s choice
• Choice of medium for participant’s instruction
• Documentation and access to materials
• Interaction with the instructor
• Certification
• Cost effectiveness
Website: http://www.globalcompliancepanel.com
For more information, contact:
GlobalCompliancePanel,
NetZealous LLC,
1000 N West Street | Suite 1200 | Wilmington | DE 19801.
Ph: 800-447-9407
About
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
Category :
Health and Fitness:Healthcare
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Healthcare Keywords :
: Risk Management, Medical Devices, US Seminar, Hazard, Mitigation, Residual risk, Safety, Failure mode, FMEA, System validation, Software verificatio
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