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FDA Regulatory Compliance for Drug and Biotech Product Training Course (Recorded)

  • Training

  • 2 Days
  • Dec 2nd 11:00 - Dec 3rd 16:00 EST
  • World Compliance Seminar
  • ID: 6021295
Description Jump to:

Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act.

In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.

12.0 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Content


Day 1FDA and its Statutory and Regulatory Requirements
FDA’s Structure and Purpose
  • The Federal Food, Drug and Cosmetic Act
  • The Code of Federal Regulations
  • Guidance, Policy Documents and Compliance Manuals
  • The Evolution of FDA Law
Brief Overview: The Products FDA Regulates and Their Pathways to Market
  • Drugs
  • Medical Devices
  • Food & Dietary Supplements
  • Cosmetics
  • Tobacco
  • Veterinary Products
Universal Requirements
  • Establishment Registration, Product Listing, User Fees, etc.
FDA Drug Development and Approval Process Considerations
  • Statutory and Regulatory Provisions
  • Citizen Petitions
  • Approvals and Clearances
    • The Drug IND, NDA, ANDA and Orphan Designation
    • Biologic’s BLA
    • Medical Device 510(k) and PMA
    • Combination Products
    • Veterinary INAD, NADA, ANADA, MUMS
  • FDA Drug Approval Process
    • Case Study #1: Suitability Petitions
    • Case Study #2: Paragraph IV Certification
  • Post Approval Submissions
  • QbD product development and design
  • Key elements of IND, NDA/ANDA applications and FDA expectations
  • Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway)
  • Post-approval changes to process, methods etc.
  • Regulatory Filings
  • Risk analysis
Statutory and Regulatory Compliance
  • The Concepts of “Adulteration” and “Misbranding”
  • Identifying Non-Compliance
    • Product Label and Labeling
    • The Internet
    • Approval and Clearance
    • Facility Inspections
    • Adverse Events
    • Recalls
    • Trade Complaints and Anonymous Tips
  • FDA’s Compliance Options, Historical Case Examples & FDA’s Website
    • Form 483s
    • Untitled Letters
    • Warning Letters
    • Import Alerts
    • Seizures
    • Recalls
    • Consent Decrees
    • Temporary and Permanent Injunctions
    • Civil and Criminal Prosecution
    • The Park Doctrine
  • Other Compliance Bodies
    • DOJ, FTC, EPA, the States, NAD
Management’s Role and Responsibilities in Compliance
  • Communication, Implementation and Decision Making
  • Quality Policy and Resourcing
  • Personnel Training
  • Escalation of issues to upper management
Corrective and Preventive Actions (CAPA)Gap Analysis
Facility Audits and Inspections
  • Internal Company Audits
    • Training the Employees
    • Use of Third-Party Auditors
    • Auditor qualifications understanding
    • Learn Key critical audit areas
    • Internal auditing procedures and schedule
    • Supplier and Customer Audits
  • FDA Inspections
  • Foreign Inspections
  • The FDA Form 483
  • Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations
    • The Written Response
    • Communication with FDA
    • Disagreements with Form 483 Observations
  • When the Form 483 Becomes a Warning Letter
Day 2
Manufacturing and Quality Controls for Drug Products
  • Management’s Role and Involvement
  • Complying with Good Manufacturing Practices “cGMPs”
  • Laboratory Quality Controls
  • Standard Operating Procedures
    • What Makes a Good SOP
    • How to Write an Adequate SOP
    • Strategies for Drafting
Recalls and Market Withdrawals
  • FDA Jurisdiction and Authority
  • Stock Rotations
  • Corrections
  • Market Withdrawals
  • Recalls
    • Recall Classifications
    • How to Conduct a Product Recall
    • Customer Communication
    • FDA Communication
    • Documentation
  • Strategies for Mitigating the Chances of a Recall
Pharmacovigilance
  • Definitions of Significant and Serious Adverse Events
  • Recording, Investigating and Reporting Complaints
  • FDA Communication
  • Strategies for Dealing with Complaints
Customs, Detentions and Import Alerts
  • The Process
  • Holds and Detentions
  • Seizure and Destruction
  • Remediating
  • The Import Alert
Rx Drug Promotion and Advertising
  • Risk Considerations
    • “Fair Balance”
    • Elements & Considerations
      • Brief Summary
      • Boxed Warning
      • Important Safety Information
  • False and Misleading Claims
    • Fair Balance
    • Superiority Claims
    • Testimonials
    • Market Research
    • Quality of Life Data
    • Other Considerations
  • Enforcement Action Examples
Emerging Compliance Trends
  • Counterfeit drug issues and growing concerns
  • Drug shortage crisis
  • Biosimilar approval pathways
  • Others
Other Compliance IssuesQuestions & Answers and Closing Thoughts

Course Provider

  • Karl M. Nobert

  • Karl M. Nobert,
    Michael Best & Friedrich LLP

    Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

    He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Who Should Attend

This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance: 

  • QA/QC analytical chemists
  • QA/QC directors, managers
  • Investigators in QA/QC
  • Manufacturing/Production
  • Research and Development
  • Project management
  • Manufacturing personnel
  • CROs analysts
  • Technical liaison
  • Regulatory affairs personnel
  • CMC specialists
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Quality auditors
  • Document control specialists
  • New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

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