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

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Training
2 Days
Mar 7th 11:00 - Mar 8th 17:00 EST
World Compliance Seminar
ID: 5880001

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 01FDA 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 02

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,
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.

Course Content

Course Provider

Who Should Attend

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