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Description
The future of regulatory compliance and GMP in pharma, biotech, and medical device industries is being transformed by AI. AI-powered regulatory intelligence, predictive analytics, and automation are significantly improving compliance efficiency, but regulatory agencies are still defining the scope of AI governance in GMP.
- The current and future regulatory frameworks for AI-driven compliance and quality management
- Key AI applications in pharma, biotech, and medical device manufacturing
- Challenges in AI validation, regulatory submissions, and AI-driven decision-making
- Case studies of AI implementation in Good Manufacturing Practice (GMP) environments.
By the end of this session, attendees will:
- Understand AI’s impact on regulatory compliance and GMP in the life sciences sector
- Learn how to implement AI within regulatory frameworks while avoiding non-compliance risks
- Gain insights into regulatory expectations from global agencies like FDA, EMA, and MHRA.
Areas Covered
- AI-driven automation in GMP compliance
- AI and regulatory submissions (how AI accelerates submissions)
- AI-powered pharmacovigilance & post-market surveillance
- Predictive analytics in GMP manufacturing & process optimization
- Ensuring AI-driven data integrity and audit readiness
- Regulatory challenges and best practices for AI validation
- Case studies: AI in pharma, biotech, and medical device compliance.
Background
Artificial Intelligence (AI) is revolutionizing regulatory compliance, quality assurance, and GMP practices across the pharmaceutical, biotech, and medical device industries. As regulatory agencies such as the FDA, EMA, MHRA, and PMDA evolve their frameworks, AI is playing an increasingly vital role in automating compliance, ensuring data integrity, enhancing quality systems, and optimizing manufacturing processes.
This webinar, led by Dr. David Lim, Ph.D., will provide an in-depth exploration of how AI is reshaping regulatory affairs, GMP compliance, and quality management systems (QMS), helping companies navigate challenges in AI validation, regulatory expectations, and implementation strategies.
Why Should You Attend
Regulatory agencies are tightening compliance requirements while companies struggle with manual, paper-based, and outdated quality management systems. AI is a game-changer, offering the potential to:
- Automate batch record reviews, CAPA investigations, and regulatory submissions
- Enhance risk-based QMS, audit readiness, and post-market surveillance
- Predict and prevent manufacturing deviations through AI-powered analytics
- Ensure real-time compliance and data integrity with AI-driven monitoring
However, the regulatory landscape for AI in GMP compliance is still evolving, and improper AI implementation can lead to compliance risks, FDA warnings, and regulatory rejections.
This webinar will help you understand how to leverage AI responsibly and compliantly while avoiding pitfalls that could result in compliance failures and financial losses.
Who Should Attend
- Regulatory Affairs & Compliance
- Quality Assurance (QA) & Quality Control (QC)
- Good Manufacturing Practice (GMP) & GxP Compliance
- Pharmaceutical & Biotech Manufacturing
- Medical Device Quality & Validation
- AI, Digital Health, and Data Science in Regulatory Affairs.
Speaker
Dr. David Lim is a seasoned ex-FDA regulatory expert with over 20 years of experience in pharmaceuticals, medical devices, in vitro diagnostics (IVDs), and biotechnology. As the President and Principal of Regulatory Doctor, he provides strategic guidance on global regulatory affairs, quality compliance, and clinical strategies.
With a strong scientific background, including a Ph.D. in biological sciences from the University of Missouri-Columbia and advanced training from esteemed institutions such as Caltech, Duke University, UC Berkeley and FDA, Dr. Lim has successfully led hundreds of FDA consulting projects, including Pre-Submission, 510(k), PMA, IDE/IND, and De Novo submissions. His significant expertise in 510(k) training, preparation, and submission has enabled numerous clients to navigate the complex regulatory landscape effectively.
A former Fellow Consultant at the FDA, Dr. Lim has played a crucial role in regulatory strategy and compliance for numerous entities. He is a frequent speaker and actively contributes to industry discussions on compliance and FDA policies. Passionate about education, he mentors regulatory professionals and shares his expertise through training programs, professional publications, and his YouTube channel, "Medical and Health Tips” @Medical-HealthTips.