Future of AI in Regulatory & GMP in Pharma, Biotech, and Medical Devices

Description

Artificial Intelligence (AI) is transforming regulatory compliance and Good Manufacturing Practice (GMP) in the pharmaceutical, biotechnology, and medical device industries. AI technologies such as regulatory intelligence, predictive analytics, and automation are improving compliance efficiency, quality management, and decision-making. However, global regulatory agencies are still defining how AI fits within GMP frameworks.

This webinar will cover:

• 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-based decision-making
• Real-world case studies of AI implementation in GMP environments

By the end of this session, attendees will:

• Understand how AI is reshaping regulatory compliance and GMP in the life sciences sector
• Learn to implement AI responsibly within existing regulatory frameworks
• Gain insights into global regulatory expectations from agencies such as the FDA, EMA, and MHRA

Background

AI is revolutionizing how regulatory compliance, quality assurance, and GMP practices are managed in life sciences. As regulatory bodies like the FDA, EMA, MHRA, and PMDA update their frameworks, AI is emerging as a key enabler for automating compliance, ensuring data integrity, strengthening quality systems, and improving manufacturing processes.

Led by Dr. David Lim, Ph.D., this webinar will explore how AI is transforming regulatory affairs, GMP compliance, and Quality Management Systems (QMS). Attendees will also gain insights into overcoming challenges in AI validation, understanding regulatory expectations, and developing practical implementation strategies.

Why Should You Attend?

With increasing regulatory scrutiny and outdated manual processes, companies face growing challenges in maintaining compliance. AI offers powerful solutions to streamline and modernize quality and regulatory operations.

You will learn how AI can:

• Automate batch record reviews, CAPA investigations, and regulatory submissions
• Strengthen risk-based QMS, audit readiness, and post-market surveillance
• Predict and prevent manufacturing deviations using advanced analytics
• Ensure real-time compliance and data integrity through AI-driven monitoring

However, improper AI implementation can lead to compliance risks, FDA warnings, and costly rejections. This session will help you understand how to deploy AI effectively and compliantly—minimizing risk while maximizing efficiency.

Areas Covered in the Session

• AI-driven automation in GMP compliance
• How AI accelerates regulatory submissions
• AI in pharmacovigilance and post-market surveillance
• Predictive analytics for GMP manufacturing and process optimization
• Ensuring AI-driven data integrity and audit readiness
• Regulatory challenges and best practices for AI validation
• Case studies on AI in pharma, biotech, and medical device compliance

Who Will Benefit?

This session is designed for professionals in:

• Regulatory Affairs and Compliance
• Quality Assurance (QA) and Quality Control (QC)
• GMP and GxP Compliance
• Pharmaceutical and Biotech Manufacturing
• Medical Device Quality and Validation
• AI, Digital Health, and Data Science in Regulatory Affairs

Target Associations / Societies

• Regulatory Affairs Professionals Society (RAPS)
• Association for the Advancement of Medical Instrumentation (AAMI)
• Medical Device Manufacturers Association (MDMA)
• American Society for Quality (ASQ)
• International Society for Pharmaceutical Engineering (ISPE)
• Parenteral Drug Association (PDA)
• American Association of Pharmaceutical Scientists (AAPS)
• Drug Information Association (DIA)

Speaker’s Profile

Dr. David Lim, Ph.D., is a highly experienced ex-FDA regulatory expert with over 20 years of experience across pharmaceuticals, medical devices, IVDs, and biotechnology. As the President and Principal of Regulatory Doctor, he provides strategic consulting in global regulatory affairs, quality compliance, and clinical strategy—particularly in AI-driven regulatory intelligence and GMP compliance.

Dr. Lim holds a Ph.D. in Biological Sciences from the University of Missouri-Columbia and has advanced training from Caltech, Duke University, UC Berkeley, and the FDA. He has led hundreds of FDA consulting projects, including Pre-Submission, 510(k), PMA, IDE/IND, and De Novo submissions.

Recognized as a pioneer in AI-based GMP compliance and regulatory intelligence, Dr. Lim helps companies integrate AI into regulatory and quality systems while maintaining compliance with global standards such as FDA, EMA, and ISO.

A frequent speaker and thought leader, Dr. Lim actively contributes to industry discussions on regulatory policy and AI innovation. He is also passionate about training the next generation of regulatory professionals through workshops, publications, and his YouTube channel, “Medical and Health Tips” (@Medical-HealthTips).

After Registration:
Once you register, you’ll receive a confirmation email with your login credentials and access to downloadable presentation materials. These resources can also be shared with your team for internal training and reference.

System Requirements:
Internet: A stable internet connection of at least 1 MBPS is recommended for a smooth experience.
Audio: Use a working headset or speaker with a microphone for clear audio, especially during interactive sessions.

Session Cancellation Policy:
If a session must be cancelled or rescheduled, WebinarWaves will notify all registered participants via email no later than 24 hours before the scheduled start time.

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What Attendees Are Saying:

I really enjoyed this session. The speakers did a great job keeping the content practical and easy to follow. It covered key topics we deal with daily in pharma, and I left with a few ideas I can actually put into practice. - Amanda Reynolds, Clinical Research Associate

This was a well-organized webinar. The insights on industry challenges and compliance updates were very relevant. I appreciated how the presenters explained things clearly without overcomplicating the discussion. - Kevin Martinez, Regulatory Affairs Specialist

 Very informative session. It gave me a better understanding of how different parts of pharma operations come together. - Lauren Cooper, Supply Chain Manager

I found this webinar very informative and well put together. The speakers shared practical insights that really resonated with the current pharma landscape. It was engaging throughout, and I came away with useful takeaways for my team. - Daniel Brooks, Clinical Operations Director