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LIVE WEBINAR: AI Quality Management and Practical Training

LIVE WEBINAR: AI Quality Management and Practical Training Certification Training


Next Webinar Date:TBD: Jan. XX, 2027 @ 10am ET (~3 hours)
Average Learning Time:~3-4 hours.
Method of Training:
Live, online webinar.
Program/Course ID:AI-201.WEB
Enrollment Period:12 months.
Additional Resources:Supplemental materials & activities.
Accessibility:24/7 access to eLearning program materials.
Courses:See 0 courses included with this program.
Outline/Syllabus:See individual course pages for outlines.
Post-nominal Letters:EILPro™
Digital Badge:Issued upon completion.
Catalog:AI Quality Management.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote or invoice.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with QR validation code.
  Price: $695.00 USD  

Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.

Training Program: LIVE WEBINAR: AI Quality Management and Practical Training
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment.
Description:
Biopharma Institute Reviews

This instructor-led Live Webinar introduces the basic skills required to act as an Expert-in-the-Loop™ for AI use in regulated GxP environments and deliver next-generation skilling for System Validation, Risk-Based CSA, and QRM. The cognitive learning programme combines focused lectures, facilitated discussion, polling-based knowledge checks, and practical scenario work using RiskCortex Solution.

Attendees will learn how AI, machine learning, and large language models are changing validation, data integrity, and compliance expectations; how CSV compares to Risk-Based CSA and aligns with GAMP®5 concepts; how QRM principles support Audit Assessment and inspection readiness; and how to apply risk-based critical thinking, mitigation, and controls to AI-enabled quality and compliance workflows.

This webinar is suitable for quality, validation, CSV, CSA, data integrity, IT, automation, manufacturing, laboratory, regulatory, compliance, and operational professionals who need to understand how AI can be used responsibly in GxP environments. It is also suitable for managers, project leads, business process owners, and subject matter experts who may be expected to review, approve, challenge, or oversee AI-enabled systems, tools, or outputs.

Attendees who successfully complete the on-site training and associated assignment will receive a completion certificate, alongside practical experience and temporary assignment access to the RiskCortex Solution.

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.


Outline:


  • Attendees will explore the fundamentals of AI technology, with emphasis on how large language models are being used in GxP operations.
  • The webinar will explain how AI changes validation, compliance, data integrity, and quality decision-making in regulated life sciences environments.
  • Attendees will examine the AI Trust Paradox and learn how Trust by Design™ supports safe and explainable AI adoption.
  • The webinar will compare Computer System Validation (CSV) and Risk-Based CSA (Computer Software Assurance), including Agile delivery, SDLC, and alignment with GAMP®5 concepts.
  • Attendees will learn how QRM (Quality Risk Management) principles, including ICH Q9 thinking, can be applied to AI-enabled processes and controls.
  • The webinar will introduce the Expert-in-the-Loop™role and the critical thinking behaviors needed to provide effective human oversight of AI outputs.
  • Practical on-site exercises will use RiskCortex Solution scenarios to help participants work through AI risk assessment, mitigation, control decisions, and Audit Assessment readiness.

Objectives:


Upon successful completion of this course, participants should be able to:
  • Understand how AI, machine learning, and large language models impact GxP validation, data integrity, and compliance.
  • Compare Computer System Validation (CSV) with Risk-Based Computer Software Assurance (CSA) using GAMP®5 concepts.
  • Apply Quality Risk Management (QRM) and ICH Q9 principles to evaluate and control AI-enabled quality workflows.
  • Define the responsibilities and critical thinking behaviors required for the Expert-in-the-Loop™ human oversight role.
  • Perform practical AI risk assessments, mitigations, and audit readiness reviews using the RiskCortex Solution.

Related Professional Certification Programs:


Professional Certification Program:

AI Quality Risk Management: GxP Validation & Data Integrity Professional Certification Program

Program ID: AI-201
Price: $1495.00 (USD)

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

Biopharma Institute's online training provides immediate access after enrollment. Students receive their username, password, and instructions via email directly after registering. The final assessment can be attempted as many times as necessary to achieve a passing score. Once the course is successfully completed, the certificate is generated instantly in an encrypted PDF format, featuring a watermark, unique validation code, and QR verification barcode.

Training achievements can be verified on our website using the certificate's unique ID or QR code. For professional certification programs, a digital badge is also issued, allowing students to showcase their accomplishment on platforms such as LinkedIn, Facebook, Twitter, and Badgr.

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 Our training engages students in active learning through interactive eLearning modules that are validated by independent third-party organizations for relevance, compliance, and regulatory accuracy. Each course is developed by subject matter experts (SMEs) in collaboration with instructional design professionals to maximize knowledge retention. Programs include access to regulatory references, real-life case studies, and other essential resources to support learning.

Since 2003, Biopharma Institute has helped professionals and their employers meet training requirements. Our certifications are recognized by a wide range of industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the needs of any organization. We currently offer over 300 courses covering topics such as clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity, serving the clinical research, pharmaceutical, and medical device sectors.

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

We support both small- and large-scale training initiatives, always with the same goal- providing a positive, streamlined experience for everyone involved, from students to training managers.


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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.


Have Questions? Contact Us:


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.

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For quotes or invoices please provide the titles of the course(s) and number of students.