Webinars>>Clinical Study
Regulatory Affairs Certification for New Companies

Are you involved in the pharmaceutical, medical device, or biotech industries and find FDA regulations daunting and complex? Do you want to gain a comprehensive understanding of FDA requirements and best practices to ensure compliance and expedite your products' approval process? If so, our power-packed workshop is tailor-made for you!
 
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:
  1. Develop problem-solving skills through the analysis and evaluation of complex issues encountered in regulatory affairs compliance.
  2. Assess regulatory requirements, policies, and guidelines associated with regulatory compliance issues that have been highlighted in the case studies.
  3. Analyze regulatory policy, principles, and guidelines for compliance in medical product development and use.
  4. Develop implementation strategies for ensuring regulatory affairs compliance in medical product investigations, manufacturing, development, labeling and marketing.
  5. Demonstrate their ability to construct written regulatory communications while prioritizing appropriate corrective actions or responding to regulatory compliance issues.
  6. 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

Don't miss this exclusive opportunity to become an FDA compliance champion! Secure your spot today and embark on a journey of growth, knowledge, and professional excellence.
Who will benefit: 
  • 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.
Date: December 11-12, 2023
Time: 12 PM - 3 PM EST
​Duration: 6 Hours (3 Hours Each Day)

Speaker Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on this webinar topic, please call 410-501-5777 or email: [email protected]