Regulatory Affairs (Pharmaceuticals, Regulatory Affairs Medical Devices)

Securing timely FDA approval is essential in every organization so products can be quickly delivered and introduced to the market. MITS’ Regulatory Affairs training course is designed to give professionals a nuclear edge in the management of the regulatory process, FDA approval process, and a thorough knowledge of a product’s life cycle.

PREREQUISITE:

To take this course, there are certain prerequisites required from every participant such as:

• Bachelor’s degree level in Biology, Chemistry or Engineering
• Regulatory Requirements for Medical Devices Course Training
• Regulatory Requirements for Pharmaceutical Products
• Candidate who possesses a fundamental understanding of FDA regulations is a great advantage.

COURSE OVERVIEW:

A Regulatory Affairs Personnel has several roles and responsibilities being the first-line assurance that organizational products and documentation are in compliance with regulatory bodies across the globe. The Professional Program in Regulatory Affairs reviews FDA regulations and other guiding principles, including Good Pharmaceutical Practice (GXP) concepts and ethical developments encompassing the production of drugs and dossiers for clinical trials and licensure, and offers the training course to monitor and assess these responsibilities. The course also taps on additional coursework such as the related functional areas of clinical research, process and output establishment, production and supply chain, and quality and compliance.

There are several required courses applicable to multiple programs, allowing participants to gain an advantage while he or she finds the most suitable curriculum under our comprehensive Regulatory Affairs course training.

COURSE OBJECTIVE:

The course offers an excellent introduction to the regulatory authorities whose policies and requirements must be addressed to secure compliance with the laws governing this industry. A participant will learn the steps directing to testing products in humans, authorization of products and post-approval requirements, and industry establishment.

COURSE CURRICULUM:

• Overview on the Principles of Regulatory Affairs
• BLA or NDA or MAA Submissions and Commercialization
• Understanding Balance Across Worldwide Applications
• IND or CTA Enabling Studies and Agency Platforms
• IND or CTA Preparation and Submission
• Post-Approval Activities
• Overview on the Principles of Supply Chain and Manufacturing
• Overview on the Principles of Product and Process Development
• Overview on the Principles of Quality and Compliance
• CMC Regulatory Compliance for Pharmaceutical Products

WHAT YOU’LL LEARN:

This course offers several benefits not only to the participant’s career, but also to his or her immediate organization where he or she can effectively apply such learning. Through our intensive training, lectures and exercises, a participant can successfully gain an edge in his job position, further his or her career, and help in the improvement in the organization’s product management.

• Develop an efficient job transition as you deal into the life science industry
• Improve your career as a Regulatory Affairs professional
• Gain several credits for the qualification of RAC recertification
• Establish your organization’s clinical and regulatory strategies
• Organize an educational access for advanced learning and knowledge in FDA regulations, compliance and policy

WHO NEEDS TO TAKE THIS COURSE:

MITS’ Regulatory Affairs training course is designed for individuals who are interested in ensuring regulatory compliance and develop related submissions for their organization’s goods for FDA approval. Several job positions are suitable for this course that includes functions such as addressing laws, regulations, policies and guidelines for regulated health product, health and medical devices, pharmaceuticals, biologics, and biotechnology.

Click here to request schedule and more course information.