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FDA Regulatory Compliance for Drug and Biotech Products Overview: Two Day Online Course (July 27-28, 2021)

·3-min read

Dublin, June 03, 2021 (GLOBE NEWSWIRE) -- The "Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products" conference has been added to's offering.

This course is designed to provide participants with an up-to-date understanding of the drug and biotech requirements for FDA regulatory compliance, successful approaches to compliance, and strategies for meeting the concerns of regulators.

Attendees will leave with a comprehensive understanding of FDA drug regulations and be prepared for the upcoming changes to the International Council for Harmonization(ICH) Good Clinical Practice (GCP) E6 requirements in the US. The ICH E6(R3) Draft has been released for early consultation and the important changes are covered in this course.

Additional benefits of this FDA Regulatory Compliance class include:

  • FDA inspectional authority and processes including 483s, Warning Letters, recalls, and other potential actions

  • The role of clinical data in supporting product approval

  • FDA Quality by Design initiatives

  • Update on FDA electronic submission requirements

  • The benefits of a quality management system beyond the manufacturing environment

Time: 11:00am - 5:00pm EDT

Who Should Attend:

This regulatory compliance course is designed to provide attendees with a strong foundation for understanding the drug and biotech regulatory requirements of the US FDA. The content is ideal for those looking for an introduction to regulatory compliance or who need a refresher on current compliance trends within the regulated environment.

Typical attendees include those in the following disciplines:

  • Regulatory Affairs

  • Manufacturing/Production

  • Research and Development

  • Quality Assurance & Control

  • Development and preparation of submission material

This course is ideal for new hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. All levels of experience will benefit from this course.


First Day

1. Introduction

  • FDA delegated authority and powers

  • FDA compliance: regulations, guidelines, internal agency controls

  • FDA enforcement

    • 483s

    • Warning Letters

    • Consent Decrees

    • Seizure

    • Recalls

2. Interpreting Regulations

  • Review of applicable regulations


  • CFR

    • Establishing clear criteria

    • Establishing clear SOPs and policies

    • Managing the process

3. Audits and outsourcing

  • Auditor qualifications

  • Use of contract support

  • Internal auditing procedures and schedule

    • Key critical audit areas

    • Audit expectations of site personnel

  • Staff training

4. Management Oversight

  • Quality Policy

  • Management Review

    • Escalation of issues to upper management

    • Communication, decision making and transparency across management

  • Resourcing

Second Day

5. Navigating FDA

  • Website Review

  • Investigator Operations Manual

  • Compliance Policy Guides and Program Manuals

6. Emerging Trends at the FDA

  • New compliance issues

  • Drug shortage crisis

  • Counterfeit drug issues and growing concerns

  • Biosimilar approval pathways

7. Drug Development and Approval Process

  • Drug Development

    • QbD product development and design

    • Risk analysis

    • Post approval changes to process, methods etc.

  • Regulatory Filings

    • Key elements of IND, NDA/ANDA applications and FDA expectations

    • Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway)

  • FDA Review and Approval Process

  • Post Approval Submissions

8. Successful Approaches to Compliance

  • Internal Auditing Procedure and Schedule

  • Gap Analysis

    • Regulations, Guidances and Procedures

  • Remediation Plan

    • CAPAs

    • Change Control Process

    • Assignment of resources to correct issues

  • Training Procedure and Curriculums

  • FDA communication

    • Direct communication (emails, phone calls)

    • Recalls

    • Post approval submissions - annual reports, ADE reporting

9. Summary

  • Key Issues

  • Questions and resources

For more information about this conference visit

CONTACT: CONTACT: Laura Wood, Senior Press Manager For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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