Length: 2 Days
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Fundamentals of FDA Regulations and Guidance Training by Tonex

FDA Cybersecurity Premarket Workshop

This course provides an in-depth understanding of the regulations and guidance issued by the U.S. Food and Drug Administration (FDA). It covers the regulatory processes for drugs, medical devices, food, and cosmetics, and offers practical insights into compliance and enforcement.

Learning Objectives:

  • Understand the regulatory framework of the FDA.
  • Analyze the processes for drug and device approval.
  • Evaluate FDA guidance for food and cosmetics.
  • Assess the impact of FDA regulations on industry practices.
  • Explore compliance strategies for FDA regulations.
  • Develop skills for navigating FDA enforcement actions.

Audience:

  • Regulatory affairs professionals
  • Pharmaceutical and medical device industry employees
  • Food and cosmetic industry professionals
  • Compliance officers
  • Legal professionals

Program Modules:

Module 1: Introduction to FDA and Regulatory Framework

    • Overview of the FDA and its mission
    • Historical perspective of FDA regulations
    • Key regulatory statutes and regulations
    • Organizational structure of the FDA
    • Role of the FDA in public health
    • Future trends in FDA regulation

Module 2: Drug Approval Process

    • Overview of drug development and approval
    • Investigational New Drug (IND) applications
    • New Drug Application (NDA) process
    • Biologics License Application (BLA) process
    • Post-market surveillance and reporting
    • Case studies of drug approvals

Module 3: Medical Device Regulation

    • Classification of medical devices
    • Premarket notification (510(k)) process
    • Premarket approval (PMA) process
    • Quality system regulation (QSR)
    • Post-market requirements and reporting
    • Case studies of medical device regulation

Module 4: Food and Cosmetic Regulation

    • Overview of food safety regulations
    • Dietary supplements and labeling requirements
    • Regulation of cosmetic products
    • Good Manufacturing Practices (GMP) for food and cosmetics
    • Enforcement actions and recalls
    • Case studies of food and cosmetic regulation

Module 5: Compliance Strategies for FDA Regulations

    • Developing compliance programs
    • Role of compliance officers
    • Risk management and mitigation
    • Training and education for compliance
    • Monitoring and auditing practices
    • Case studies of compliance strategies

Module 6: Navigating FDA Enforcement Actions

    • Overview of FDA enforcement actions
    • Warning letters and inspectional observations
    • Recalls, seizures, and injunctions
    • Criminal and civil penalties
    • Strategies for responding to enforcement actions
    • Case studies of FDA enforcement

 

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