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

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


Presented By Dr. David Lim
 Scheduled on Monday, April 13, 2015 at 1300 Hrs
Hosting By Compliance Trainings
Please visit us at https//compliancetrainings.co
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Contact Us 416-915-4458
We Empower, You Comply!
Big Data in FDA-Regulated Industry Best
Practices for Systematic Use
Product Id
FDB1512
Category
Food, Drugs Biologics
Scheduled On
Monday, April 13, 2015 at 1300 Hrs
Duration
60 Minutes
Speaker
Dr. David Lim
Login at https//compliancetrainings.com/si
teengine/Login.aspx
Webinar Description
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 aSystematic, Integra
ted Manner.
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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
• Companys 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

Who Will Benefit

• Regulatory Affairs
• Research and Development (Engineers and
  Scientists)
• Product Development (Engineers and Scientists)
• Clinical Affairs
• Quality
• Marketing
• Senior Management
• Contractors and subcontractors
• Consultants
• Anyone interested in the topic

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Speaker Profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is
President and Principal of Regulatory Doctor
(www.RegulatoryDoctor.com). 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 seven 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 FDAs transparency public meeting in
2009. Dr. Lim contributes to the Regulatory
Affairs Professional Society (RAPS) as an author.
Dr. Lim leads and directs all research projects
including pharmacovigilance, medical device
reporting, recalls and patient safety signals
being conducted at the Regulatory Doctor.
To Register This Webinar Please Visit
https//compliancetrainings.com/SiteEngine/Product
DetailView.aspx?idFDB1512
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