Regulatory Affairs Certification for New Companies
Date: December 11-12, 2025
Duration: 6 Hours (3 Hours Each Day)
Time: 12 PM -3 PM EST
Introducing our transformative seminar on “Regulatory Affairs Certification for New Companies.” Over the course of seven enlightening sessions, you will delve deep into the core components of FDA compliance, empowering you to achieve unparalleled success in your endeavors.
Why should you attend:
At the completion of this course, you will be able to:
- Develop problem-solving skills through the analysis and evaluation of complex issues encountered in regulatory affairs compliance.
- Assess regulatory requirements, policies, and guidelines associated with regulatory compliance issues that have been highlighted in the case studies.
- Analyze regulatory policy, principles, and guidelines for compliance in medical product development and use.
- Develop implementation strategies for ensuring regulatory affairs compliance in medical product investigations, manufacturing, development, labeling and marketing.
- Demonstrate their ability to construct written regulatory communications while prioritizing appropriate corrective actions or responding to regulatory compliance issues.
- Evaluate regulatory compliance issues across product categories.
Here’s what you’ll experience during our information-packed workshop:
- Session 1: FDA Overview – 30 Minutes
- Session 2: Good Laboratory Practice (GLP) – 60 Minutes
- Session 3: Good Clinical Practice (GCP) – 60 Minutes
- Session 4: Good Manufacturing Practice (GMP) – 60 Minutes
- Session 5: Advertising and Promotion – 60 Minutes
- Session 6: Recalls, Market Withdrawals, and Safety Alerts – 60 Minutes
- Session 7: Wrap Up – 30 Minutes
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Drug discovery and development professionals (R&D and CMC)
- Senior Management People in FDA-regulated Industries
- Clinical Trial Managers
- Project Managers and Clinical Trial Specialists
- Pharmaceutical and Biotech Industry Professionals involved in clinical trial planning and execution.
- People Investing in FDA-regulated products.
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Workshop Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
