Advanced Skills - AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program

Demonstrate your commitment to compliance, safety, and professional excellence by achieving a distinguished industry certification.

Training Provided By: RiskCortex and Biopharma Institute
Website: https://www.riskcortex.ie | https://www.biopharmainstitute.com
Outline/Syllabus: See individual course pages for outlines.

Description:

This advanced professional certification program is designed to prepare life sciences professionals to perform the increasingly important role of the Expert-in-the-Loop (EIL) in AI-enabled regulated environments. As Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs) become more deeply integrated into software and decision-making across the pharmaceutical, medical device, biotechnology, and clinical research sectors, the need for skilled human oversight has become essential. This program helps participants move beyond a traditional document-centered compliance mindset and adopt a more modern, risk-based Computer Software Assurance (CSA) approach grounded in critical thinking, sound judgment, and regulatory rigor.

The Advanced Skills: AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program builds on foundational Expert-in-the-Loop concepts and provides participants with deeper insight into how AI can be effectively managed in highly regulated organizations. This live webinar includes 7 days of 24/7 access to the RiskCortex AI Risk Compliance Application, giving participants the opportunity to strengthen their skills through practical application and independent exploration.

Prerequisite:
Completion of AI-201, Basic Skills: AI Regulatory Compliance Management: Expert-in-the-Loop Professional Certification Program (included with this program) is required before participants may proceed with the remainder of AI-301 content described below.

AI Regulatory Compliance Management:
In this advanced module, participants will learn how to apply the Expert-in-the-Loop role in practice to challenge, assess, and strengthen AI-supported compliance activities. The session will include a live scenario-based demonstration of an agentic AI risk assessment solution, showing how the Expert-in-the-Loop applies critical thinking, oversight, and regulatory judgment to evaluate AI outputs and support sound decision-making.

Hands-On Access to an AI Regulatory Compliance Management Application:
Participants will receive a practical exercise to complete independently using their 7-day access to the RiskCortex AI Regulatory Compliance Management Application. This hands-on component is designed to reinforce key concepts from the certification program and provide valuable experience applying AI tools within a compliance-focused life sciences environment.

Regulation of the Industry:
This session provides an overview of the regulatory framework governing the life sciences industry and introduces participants to major regulatory authorities and important sources of guidance related to GMP, GCP, and GLP. The session also covers key compliance topics including Computer Software Assurance (CSA), 21 CFR Part 11, and Data Integrity requirements under 21 CFR Parts 211 and 212.

Final Assessment:
Multiple-choice mastery assessment.

Who Will Benefit from This Module?
This module is designed for mid-level and senior professionals across the life sciences industries who want to expand their expertise and develop the advanced knowledge and judgment required to succeed in the Expert-in-the-Loop role.

Category:
Good Manufacturing Practice, clinical trials, nonclinical studies, drug safety, regulatory affairs, quality, and compliance. The concepts presented in this program are broadly applicable across all GxP-regulated areas.

Learning Objectives:

• Understand why AI outputs must be critically reviewed and challenged by a qualified Expert-in-the-Loop due to risks such as hallucinations, bias, incomplete results, and performance drift over time
• Develop a deeper understanding of the Expert-in-the-Loop role and the core skills required for success through a live scenario-based demonstration of an agentic AI risk assessment solution
• Learn how to apply critical thinking to evaluate AI outputs and determine whether results are accurate, complete, appropriate, and fit for use
• Engage directly with the trainer during the live demonstration by asking questions and exploring practical compliance considerations
• Strengthen understanding of risk assessment and risk mitigation in computer system validation and AI-supported compliance processes
• Understand how CSA and GAMP 5, 2nd Edition concepts can be applied by the Expert-in-the-Loop to support the management and oversight of AI in regulated environments
• Gain an overview of the regulatory framework governing the life sciences industry
• Identify key sources of GxP laws, regulations, and guidance

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Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products.

These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry.

This program includes these courses:

(Click on course links below to see outline/syllabus)

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	Individual Course w/Certificate of Completion: Basic Skills - AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program Enroll Here  Learn More Course ID: AI-201 Duration: 3-6 hours Price: Included
	Individual Course w/Certificate of Completion: Advanced Skills - AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program Enroll Here  Learn More Course ID: AI-301 Duration: 6-9 hours Price: Included

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Additional Information:

Certification Requirements: To earn a certificate, students must complete the entire program and pass an online, multiple-choice final assessment for each course within 12 months of enrollment. Once these requirements are met, a certificate of completion is instantly available in PDF format.

Biopharma Institute's online training offers immediate access upon enrollment. Students receive their username, password, and instructions by email right after registration. The final assessment may be attempted as many times as necessary to achieve a passing score.

When all training requirements are fulfilled, a professional certification is awarded and can be verified instantly on our website using the unique ID code printed on the certificate. The certificate is issued in encrypted PDF format, featuring a watermark, unique validation code, and QR verification barcode. In addition, a digital badge is provided, documenting all completed courses within the program. Digital badges can be displayed on platforms such as LinkedIn, Facebook, Badgr, and other networking sites to showcase achievements.

Certificates and digital badges include the completion date but do not display an expiration date. Compliance training is generally considered valid for up to three years, and many organizations schedule refresher training every one to three years to maintain alignment with evolving regulations, standards, and GxP expectations. Biopharma Institute does not assign a universal expiration date as it recognizes that the validity period or recertification interval for each individual worker should be determined by each individual organization's quality management team.

Benefits of Being Certified by Biopharma Institute: Biopharma Institute's training engages students in active learning through interactive eLearning modules validated by independent third parties for relevance, regulatory accuracy, and compliance. Courses are developed by subject matter experts (SMEs) and instructional design professionals to maximize knowledge retention. Programs include access to regulatory references, real-world case studies, and other essential resources to support learning.

Since 2003, Biopharma Institute has supported professionals and employers in meeting their training requirements. Our certifications are recognized across industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the unique needs of any organization. We offer over 300 courses covering clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device sectors.

Employee / Corporate Training: For organizations seeking cost-effective employee training without the need for travel, webinars, or in-person sessions, Biopharma Institute is the trusted training partner. Our programs deliver effective, engaging, self-paced learning that fits seamlessly into employees' daily routines. All eLearning modules are SCORM-compliant and compatible with most corporate learning management systems (LMS).

We accommodate both small and large-scale training initiatives with the same commitment- to create a positive, streamlined experience for everyone involved, from students to training managers.