FDA                                                                                             Introduction, Objective & Purpose, FDA Inspections, Management Reviews, Quality Systems & Policies, Reports                                           Primary Information Services                                                   Home. Ordering Information. Contact

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Introduction
  • Like all trade unions, the FDA is a democratic organisation. Members elect representatives to sit on the FDA's ruling executive committee as well as the general secretary and the president. Overall policy is controlled by the Annual Delegate Conference which meets every year in May. All FDA branches are entitled to send delegates to the conference.
  • Branches are the basic unit of FDA organisation. Most departments and public bodies employing FDA members have their own branch, although some small workplaces are amalgamated into a single branch. Most members in executive agencies are in a common branch with colleagues from the parent department.
  • Each branch is run by a small committee and has an elected convenor (chair) and secretary. Many routine negotiations and personal cases are handled by branch officials, but each branch has a designated negotiator at head office who handles more serious cases and generally advises the branch on professional and employment issues.

Objectives and Purposes

  • The US Food and Drug Administration (FDA) quality system regulation specifies a minimum set of requirements that device manufacturers must meet from design and development through installation and servicing.

  • The FDA holds senior management accountable for the quality system, which includes allocating sufficient resources to meet the regulatory obligations. During formal  management review the overall health of the organisation is presented in terms of compliance, nonconformities, customer complaints, resources, etc. Senior management must be engaged and receptive to authorising adjustments as necessary to ensure the continued suitability of the quality system. 

  • FDA must maintain the balance of protecting and promoting public health. US consumers rely on FDA to protect them from unsafe medical products and contaminated food. In determining whether a new product can be marketed to consumers FDA must make a determination of the benefit versus risk based on the best available science. New information may later become available that will require revising our earlier assessment of benefits and risks.

FDA Inspections

  • FDA enforces many regulations that affect clinical trial and laboratory sites, including good laboratory practices, good clinical practices, human subjects protection and requirements for institutional review boards and clinical investigators. FDA also conducts inspections to audit data used in approval applications.
  • FDA investigators follow the same basic procedures whether they're inspecting a large manufacturing plant or a small clinical trial facility. Herein lies the challenge for those smaller facilities. Clinical trial and laboratory sites are more likely to be inexperienced with FDA inspections than are manufacturers, and operations of all sizes and types have learned the hard way that inexperience can result in less than optimal interactions with an investigator.

Report

  • FDA has a responsibility to protect the public health but it cannot do this important mission alone. FDA cannot personally supervise/inspect the design, testing, production or use of every medical device, drug, food or cosmetic product. FDA must work effectively with academia, health care professionals, consumers, manufacturers, professional organizations and others as partners to achieve the important outcome of protecting the public health. 

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