Big Data in FDA-Regulated Industry – Best Practices for Systematic Use

In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity to learn about practical, actionable and sustainable approaches to maximally use the big data. In particular, the speaker will share how to most effectively identify and use the big data for practical application to your business in FDA-regulated industry (drugs, medical devices including IVDs, dietary supplements, cosmetics, etc.). This webinar will help you bring significant benefits including detailed strategies of how to use big data to your business practices and organization, tremendously helping you save enormous resources (time, energy and money) and beyond.

In this 60-min presentation, the speaker will guide you through the details of how to identify and use big data for your maximum benefits applicable to FDA-regulated industry.

At the end of this seminar, you will learn how to develop and implement best practices to systematically use big data using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive strategy in a Systematic, Integrated Manner.

Areas Covered in the Session :

  • Applicable Laws, Regulations, Guidance, Rules, Standards
  • Definitions
  • Big Data Sources in Pharmaceuticals and Medical Devices
  • Power of Big Data
  • Data Mining
  • Drug Safety Data and Signals
  • Medical Device Safety Data
  • Solving Big Problems Using Big Data
  • Science Using Big Data
  • Big Data, Security and Privacy Matters
  • Big Data v. Drug Discovery
  • Revolution in FDA-Regulated Industry Using Big Data
  • Company’s Views on Big Data
  • Big Data: Current Trends
  • Big Data Driven Medicines
  • Big Data: Legal, Ethical and Policy Issues
  • Failure to Use Big Data
  • Inadequate Use of Big Data
  • Big Data Management
  • Big Data: Opportunities
  • Big Data: Challenges
  • Post-marketing surveillance
  • Systematic Use of Big Data: Best Practices
  • Speaker’s PASS-IT Suggestions/Recommendations
  • Speaker’s Experience and Actual Cases
  • Conclusion

Who Should Attend:

  • Quality Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Senior Management
  • Marketing Departments
  • Product Development Professionals
  • Clinical Affairs Professionals
  • Contractors and subcontractors
  • Consultants
  • Everyone interested in the topic


Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance