Training Overview

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.

Course Agenda

Time 11:00 AM - 05:00 PM EDT

FDA and its Statutory and Regulatory Requirements

FDA’s Structure and Purpose

  • The Federal Food, Drug and Cosmetic Act
  • The Code of Federal Regulations
  • Guidane, Policy Documents and Compliance Manuals
  • The Evolution of FDA Law
  • www.fda.gov

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 #: 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 Clearane
  • 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

Course Agenda Day 2

Time 11:00 AM - 05:00 PM EDT

Manufacturing and Quality Controls for Drug Products

  • Management’s Role and Involvement
  • Complying with the 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 Compliants
  • 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 Issues

Questions & Answers and Closing Thoughts 



Who Should Attend this FDA Training

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.



Faculty Karl M. Nobert (25+ yrs exp)

Senior Counsel Michael Best & Friedrich LLP - USA

Founder of ReCellerate Inc., a veterinary pharmaceutical company, that develops stem cell-based drug products for dogs, cats and horses. In his role as President and Regulatory Counsel, Karl oversaw the company’s FDA Drug Approval Program for six (currently pending) drug applications for products intended to treat and repair various disease conditions and injuries. Some of these investigative drugs are intended for osteoarthritis in dogs, inflammatory bowel disease in cats, and exercise induced pulmonary hemorrhage in horses.

Represented two of the 10 largest veterinary drug companies in the world. This work included providing the companies with ongoing regulatory advice about FDA’s oversight of veterinary products, drafting guidelines for clinical study monitoring, evaluating new products for proposed acquisition, and counseling on the cross-border distribution and sale of animal products. 

Engaged with FDA on behalf of a client to resolve identified observations and deficiencies (FDA Form 483) during a facility inspection. Drafted response to cited observations for submission to FDA

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