Basic Skills - AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program
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Price: $3590.00 USD |
Download Demonstrate your commitment to compliance, safety, and professional excellence by achieving a distinguished industry certification. Training Provided By: RiskCortex and Biopharma InstituteWebsite: https://www.riskcortex.ie | https://www.biopharmainstitute.com Outline/Syllabus: See individual course pages for outlines. Description: The Basic Skills: AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program is designed to prepare life sciences professionals for one of the most important emerging roles in regulated industry: the Expert-in-the-Loop. As Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs) become increasingly integrated into software and decision-making across the pharmaceutical, medical device, biotechnology, and clinical research sectors, the need for qualified human oversight has never been greater. 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 awareness. The goal of this professional certification program is to equip participants with the knowledge and practical skills needed to guide AI responsibly in highly regulated environments. Students will learn how the Expert-in-the-Loop helps ensure AI outputs are accurate, safe, compliant, and effective, while strengthening decision-making and reducing regulatory and operational risk. This live webinar provides a practical and engaging introduction to AI applications and their growing use in highly regulated organizations, including those operating in the pharmaceutical, medical device, and clinical research industries. A key feature of this program is the hands-on use of the RiskCortex regulatory intelligence platform. Participants will complete a practical activity using the RiskCortex AI application, providing valuable real-world experience in applying AI tools within a regulatory compliance context. The program also provides practical guidance on the use of AI across a range of critical regulated functions, including Laboratory Systems, Manufacturing Execution Systems (MES), Clinical Operations / Trial Master File (TMF & eTMF), Enterprise Resource Planning (ERP) Systems, Technology Transfer, Quality Management Systems (QMS), Quality Audits, Regulatory Submissions, and Medical Device operations and products. Program Sections AI Regulatory Compliance Management: This section introduces participants to the foundational concepts needed to manage AI in regulated environments. Topics include the principles of risk-based and critical-thinking approaches to computer system validation (CSV), the transition to Computer Software Assurance (CSA), and the application of GAMP 5, 2nd Edition. Participants will also explore core AI concepts, the risks of relying on AI outputs without appropriate human oversight, and the essential role of the Expert-in-the-Loop in improving accuracy, completeness, and decision-making. In addition, the program reviews FDA 21 CFR Part 11 requirements for electronic records and signatures, as well as data integrity expectations relevant to AI-enabled software. Scenario-Based Demo: Participants will experience a live, scenario-based demonstration of an agentic AI risk assessment solution, illustrating how the Expert-in-the-Loop applies critical thinking and oversight in practice within a regulated compliance setting. 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 key sources of guidance related to GMP, GCP, and GLP. The session also addresses important compliance topics including Computer Software Assurance (CSA), 21 CFR Part 11, and Data Integrity requirements under 21 CFR Parts 211 and 212. Hands-On Activity: Participants will complete a hands-on exercise using the RiskCortex AI regulatory intelligence platform, allowing them to apply concepts learned in the program and gain practical experience working with AI in a compliance-focused environment. Final Assessment: Multiple-choice mastery assessment. Who Will Benefit from This Program? This module is designed for mid-level and senior professionals across the life sciences industries who want to expand their expertise and position themselves for success in the emerging 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:
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.
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| Basic Skills - AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification ProgramCourse ID: AI-201Duration: 3-6 hours Price: Included |
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.
Benefits of Training with Biopharma Institute
| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
| Self-Paced eLearning: | Enjoy 24/7 access to all course materials and assessments for 12 months. |
| Open Enrollment: | No prerequisites or prior work experience required to start. |
| Expert-Developed Content: | Courses are designed by subject matter experts (SMEs) in their respective fields. |
| Up-to-Date & Validated: | Training is regularly updated to meet current regulations and is third-party validated or accredited. |
| Optimized for Learning: | Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention. |
| Secure Access: | Encrypted connections, firewalls, and daily malware scans ensure security and system performance. |
| Flexible Assessments: | Multiple-choice exams can be retaken until a passing score is achieved. |
| Instant Certificates: | Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification. |
| Training Verification: | Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications. |
| Manager Access: | A secure portal allows managers to view and download enrollment reports, training records, account balances, and more. |
| SCORM-Compliant: | Courses can be integrated directly into most corporate Learning Management Systems (LMS). |
| Purchase Orders: | We accept POs from all companies. Request an invoice to start the procurement process. |
| Employer Reimbursement: | Some employers may cover training costs -check your company's reimbursement policy. |
| Financial Assistance: | Payment plans are available for eligible learners, or purchase courses individually as needed. |
| Career Advancement: | Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills. |
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Use the form below to request more information about our programs. You can also request a quote for group training or an invoice to generate a company purchase order. For quotes or invoices, please include the course title(s) and the number of students.
