Objective , Purpose, FDA Inspections, Management Reviews, Warning Letters, Casa Study, Rules & Regulations
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  • The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
  • 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.
  • 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.
  • Businesses that manufacture FDA-regulated products are not the only ones that can be inspected by the U.S. Food & Drug Administration at any time. FDA also inspects clinical trial sites (studies in humans) and nonclinical laboratories that conduct animal, plant or microorganism studies used in FDA applications for drugs, biologics, or devices.
  • An inspection can be comprehensive, focused on a specific issue or set of issues, or in response to a reported problem. More than one investigator may be involved. Investigation techniques may include observing operations, examining equipment, reviewing documents, collecting product samples, and interviewing employees.
  • The Food and Drug Administration (FDA) receives new drug applications (NDAs) from sponsors, typically pharmaceutical companies, and reviews these applications for scientific evidence pertaining to the safety and efficacy of drugs. Based on its assessments, the FDA determines whether drugs can be marketed in the United States.
  • In the quality systems model described by FDA, management should play an integral role in the design, implementation, and
    management of the quality system, as their leadership is intrinsically tied to the success of the system.
  • Management can support the quality system through actively participating in system design, implementation, and monitoring, including system review; advocating continual improvement of quality system operations; and allocating necessary resources to the
  • The guidance document states that significant overlap exists between the elements of a quality system and the existing cGMP regulation requirements for manufacturing operations, but reminds manufacturers that FDA enforcement programs
    and inspectional coverage remain based on the regulations.
  • The purpose of internal audits is to identify nonconformities with the quality system and alert the management responsible
    for the nonconformities so they can investigate the cause and take necessary corrective action.
  • FDA also conducts inspections to audit data used in approval applications.
Introduction & Applicability
  • About the FDA
  • Food and Drug Administration
  • Protecting the U.S. Food Supply
Objective & Purpose
  • Aligning Quality and Business Objectives for Success
  • The Extra Work that goes into Building a Manufacturing Facility when it is FDA-Regulated
  • AED for Pediatric Patients
  • FDA Strategic Action Plan
  • FDA Uses EA to Standardize and Save with Consolidation Effort
FDA Inspections
  • FDA Audits of Clinical Investigators
  • FDA Audits-What To Expect When You Are Inspected
  • U.S. FDA Approach to Auditing Including QSIT
  • FDA Inspections of Clinical Investigators
  • The FDA Inspector Cometh
  • Hosting FDA Inspections
  • How to Manage an FDA Inspection
  • Points to Consider When Preparing for an FDA Inspection under the QSIT Management Controls Subsystem
  • FDA Oversight of Clinical Investigators
  • A primer to the FDA audit process for clinical trials
  • Preparing for an FDA inspection
  • FDA's Medical Device Inspection Process
  • Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products
  • Surviving an FDA Inspection:
    An Industry Perspective
Management Reviews
  • Clinical Review of Drugs to Reduce the Risk of Cancer
  • FDA’s Review Process for New Drug Applications
  • Some Remarks About “Approval"
  • ORA Laboratory Procedure
  • FDA Review Principles
  • Report of Review of the Food and Drug Administration’s Internal Controls Over Its Purchase Card Activities
  • QSIT Management Controls
Warning Letters
  • FDA Warning Letters
  • Lessons Learned from FDA Warning Letters
  • FDA Warning Letters about Products
  • FDA Warning Letter Report
  • Responding to an FDA warning letter
  • FDA Warning Letters Summary
  • Current Trends in FDA Warning Letters
  • FDA Warning Letters - U.S.A Freedom of Information Act
Quality Systems & Policies
  • FDA’s Quality Systems Approach
  • Quality
  • Quality Management Systems
  • Navigating Two FDA Quality Systems
  • Good Manufacturing Practices (GMP) / Quality System (QS) Regulation
  • Quality System Framework for Internal Activities
Complaint handling
  • Medical Device Appeals and Complaints
  • Complying with US FDA for the Life Sciences Industry
  • FDA Evaluation of Consumer Complaints
  • Complaints Management
  • Detecting and Handling Scientific
    Misconduct and Persistent
  • Camstar’s Complaint Management
  • Establishing regulatory compliance in the medical device industry
  • Implementing Corporate Compliance Programs
  • Tescom is Clean Service Complaint with FDA cGMP Requirement
  • FDA Manufacturing Regulatory Compliance
Rules and Regulations
  • Cell Therapy in Multiple
    Sclerosis: FDA Regulatory Issues
  • Life Sciences in China: Regulatory issues
  • Regulatory Issues Surrounding the Use of Companion Animals in Clinical Investigations, Trials, and Studies
  • Drug Development & Regulatory
    Issues in Pediatric Oncology
  • Regulatory Issues: FDA considers functional foods
  • Regulatory Issues in Genotyping
    Metabolizing Enzymes- CDER Perspective
  • Regulatory Compliance and Validation Issue
  • Safety and Regulatory Issues Associated with Herbal Flavored Vinegars and Oils
  • Food Advertising and Labeling: Regulatory Issues and Evidence
  • FDA Licensing of Islet Transplantation
  • Federal Register Rules and Regulations
  • Overstating FDA Regulatory Prospects Puts Stock at Risk
  • Regulatory Issues for Drug Manufacturing
Material / Purchasing controls
  • Review of Purchasing Controls and Q.S. Regulation
  • FDA-Approved Rapid HIV Antibody Screening Tests – Purchasing Details
  • FDA Makes Quality the Rule
Case Study
  • FDA/CDER Perspective on Juvenile Animal Studies for Safety Assessment of Pediatric Drugs for Drugs
  • Implementing User Fees in the FDA
  • The Exclusion of FDA Materials from the FDA's Division of Drug Marketing,  Advertising and Communications and Adverse Event Report
  • Safe Handling Labels for Meat and Poultry: A Case Study in Information Policy
  • Growth- Enhanced Salmon
  • Outside Leveraging Case Study: Making Stone Soup
  • FDA 510(k) Services

CAPA process

  • Corrective and Preventive Action
  • CAPA
  • Issued by Standards Unit, Evaluations and Standards Laboratory Centre for Infections
  • Nonconformance and Corrective and
    Preventive Action
  • Having an effective CAPA Process
  • Corrective & Preventive Action Management
  • QSIT Corrective & Preventive Actions


  • Guidelines for the Creation of Analysis Data Files and Documentation of Statistical Analyses for Submission to the FDA
  • Guidelines for industry
  • FDA issues guidelines for fresh-cut produce
  • CBER Guidances / Guidelines / Points to Consider
  • Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
  • FDA Guidelines for Magnetic Resonance Equipment Safety
  • The Plant Material for Botanical Drug Products
  • Public Health Reasons/ Administrative Guidelines
  • FDA Regulatory Guidance for Toxins
    and Contaminants
  • Guidelines for Retail and Food services Establishments Affected by Natural or Other Disasters


  • FDA report says Able Labs fudged drug tests
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • FDA Office of Management Annual Performance Report
  • FDA Report to CFP Executive Board Meeting
  • FDA failure puts lives in danger, report says
  • FDA Report Says Nation's Health at Risk
  • Memorandum of Understanding
  • FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types
  • FDA Report to PharmPAC
  • cGMP’s for Managers and Leaders

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