DUBLIN--(BUSINESS WIRE)--The "6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems" webinar has been added to ResearchAndMarkets.com's offering.
GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
Quality management system ensures that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control, and quality improvement.
Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations.
In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described. Documentation is a critical tool for ensuring GxP/GMP compliance.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
In this webinar, the connection between GxP/GMP and document control will be discussed. Details of document control procedures and the role of Quality Assurance in the documentation systems are described. GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements will be reviewed. There is also a review of change control procedure and how it should be used in GxP/GMP environment.
Information governance and data security are the high priorities in any organization but especially in a regulated industry.
E-Discovery preparedness makes it imperative for organizations to develop an enterprise wide strategy to manage the volume of electronic information. The discovery process affects many individuals in an organization, not just lawyers and others involved in discovery, but also IT professionals and records managers who have to be prepared to produce electronic content for discovery and litigation.
Crisis preparedness is the high priority in any organization but especially in a regulated industry. In this webinar, you will learn the framework of GxP/GMP regulations, information governance procedures and how to implement them.
You will also learn how to implement data security, e-discovery and crisis preparedness.
Who Should Attend?
- Quality Assurance
- Compliance
- IT
- Medical Affairs
- Documentation Management/Document Control
Agenda
- GxP/GMP Framework
- Quality Management System
- Quality Audits
- GxP/GMP Requirements for Documentation
- GxP/GMP Requirements for Information Technology
- IT Systems Validation
- Change Control
- Information Governance
- Data Security
- E-Discovery
- Crisis Preparedness
For more information about this webinar visit https://www.researchandmarkets.com/r/76ehdh
