Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products: Two Day Virtual Seminar Online (July 27-28, 2021) - Worldcomplianceseminars.com

RALEIGH, N.C., June 30, 2021 (GLOBE NEWSWIRE) -- The “Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products” seminar has been added to worldcomplianceseminars.com offering, provided by WCS Consulting.

The U.S. Food and Drug Administration (FDA) continues to expand its powerful regulatory oversight hence understanding the guidelines, philosophy and practical approach to FDA compliance proves to be better way to manage if not prepare for FDA inspections and 483s. 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.

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 all covered in this course.

The new highlights of this FDA Regulatory compliance course online 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 | 08:00 AM PDT - 02:00 PM PDT (12 hours)

This course “Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products Course” is available as a live virtual seminar on July 27-28, 2021.

We are helping to find the right course for you. WCS Consulting Inc. has the top industry experts and consultants in the country. Our onsite trainers and consultants provide you with the most useful and up-to-date information available at the most reasonable price. Our trainers and consultants will exceed your expectations by providing top quality training that will meet your training objectives. For more information, visit https://worldcomplianceseminars.com Contact us for your Life science regulatory compliance training. Booking Toll Free 844-267-7299 or email us support@worldcomplianceseminars.com. This course is among a library of certified courses that is delivered in an innovative way to support learning, engagement, measurement, and achievement for professionals on the go.

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 FDA course online 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.

A detailed agenda is below:
First Day Agenda
Session 1: 11 am -01:00 pm EDT
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

FDC ACT

CFR

• Establishing clear criteria
• Establishing clear SOPs and policies
• Managing the process
  

20 minutes Break

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

20 minutes Break

Session 3: 03:20 - 05:00 PM EST
4. Management Oversight

Quality Policy

Management Review

• Escalation of issues to upper management
• Communication, decision making and transparency across management

Resourcing

Second Day Agenda
Session 1: 11:00 -12:30 PM EST
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

15 minutes Break

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

20 minutes Break

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

Session End time : 5:00 PM EST

For more information about this FDA training course online visit https://worldcomplianceseminars.com/p/comprehensive-overview-of-fda-regulatory-compliance-training

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