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

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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 to be Covered:

Applicable Laws, Regulations, Guidance, Rules, Standards
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

Who will Benefit:

Regulatory Affairs
Research and Development (Engineers and Scientists)
Product Development (Engineers and Scientists)
Clinical Affairs
Senior Management
Contractors and subcontractors
Anyone 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