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
Contacts
Worldcomplianceseminars.com
David Jones , Senior Press Manager
support@worldcomplianceseminars.com
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