FDA Regulatory Compliance for Drug and Biotech Products Overview: Two Day Online Course (July 27-28, 2021)
Dublin, June 03, 2021 (GLOBE NEWSWIRE) -- The "Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products" conference has been added to ResearchAndMarkets.com'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.
Agenda:
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
FDC ACT
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 https://www.researchandmarkets.com/r/ft1eje
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com 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