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The FDA (Food and Drug Administration) Regulatory Compliance for Pharma and Biotech Products (July 27-28, 2021)

  • ID: 5360356
  • Conference
  • Region: Global
  • 2 Days
  • World Compliance Seminar
  • Conference Dates: July 27-28, 2021

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

This course which prepares attendees with an mastery of the Pharma and biotech requirements for FDA regulatory compliance, latest approaches to compliance, and strategies for meeting the concerns of regulators.

Benefits of attending:

  • FDA Drug Regulation Understanding
  • Good Clinical Practice (GCP)
  • E6 requirements in the US.
  • The ICH E6(R3) Draft
  • International Council for Harmonization(ICH)
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First Day

Session 1: 11 am -01:00 pm EDT

1. Overview

  • 483s & Warning Letters
  • Consent Decrees
  • Seizure
  • FDA delegated authority
  • FDA compliance: regulations, guidelines, internal agency controls
  • FDA enforcement and FDA Recalls

2. Regulations Explain

  • CFR and FDC ACT
  • CFR Establishing clear SOPs and policies
  • Managing the CFR process
  • Applicable CFR Regulations Review

20 minutes Break

Session 2: 1:20 -03:00 pm EST

3. FDA Audits

  • Training the Employees
  • Audit expectations of site personnel
  • Use of contract support
  • Learn Key critical audit areas
  • Auditor qualifications understanding
  • Internal auditing procedures and schedule

20 minutes Break

Session 3: 03:20 - 05:00 PM EST

4. Management Overlooking

  • Management Review
  • Communication, decision making and transparency across management
  • Quality Policy and Resourcing
  • Escalation of issues to upper management

Session End time: 5 pm EST

Second Day

Session 1: 11:00 -12:30 PM EST

5. FDA Emerging Trends

  • Biosimilar approval pathways
  • Latest compliance issues
  • Drug shortage crisis
  • Counterfeit drug issues and growing concerns

6. FDA Navigating

  • Understand Website Review
  • Operations Manual Investigator
  • Compliance Program Manuals and Policy Guides

15 minutes Break

Session 2: 12:45 - 03:00 PM EST

7. Compliance Fortunate Approaches

  • Gap Analysis
  • Corrective and Preventive Actions (CAPA)
  • FDA Recalls
  • Post-approval submissions - annual reports, ADE reporting
  • Regulations, Guidance’s, Procedures and Remediation Plan
  • Change Control Process
  • Training Procedure and Curriculums
  • FDA communication
  • Direct communication (emails, phone calls)
  • Internal Auditing Procedure and Schedule
  • Assignment of resources to correct issues

20 minutes Break

Session 3: 03:20-05:00 pm EST

8. FDA Drug Development and Approval Process

  • FDA Review and Approval Process
  • FDA Drug Development
  • 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

9. Summary

  • Key Challenges
  • Questions and resources

Session End Time: 5:00 PM EST

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  • 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.

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

  • 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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