FDA Laws and Regulations Governing Drugs, Medical Devices and Combination Products

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Oct 10, 2017
60 minutes
Product Description

Recent Industry Changes Affecting FDA-regulated Food, Drugs, Cosmetics and Medical Devices

Firms operating in an FDA-regulated industry should be well-aware of and understand what laws and regulations apply to FDA-regulated products (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics).

This session by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will help you learn the laws and regulations governing food, drugs, biologics, cosmetics, combination products and medical devices including in vitro diagnostic medical devices (IVDs). David will share key statutory and regulatory requirements as set out in the laws and regulations and will provide an overview of recent changes and amendments to important FDA regulations. Domestic and foreign firms, who are involved in either directly or indirectly handling medical products (food, drugs, cosmetics, combination products, medical devices and IVDs) will become aware of the regulations that impact these products.

Session Highlights

  • Overview of laws and regulations including recent amendments
  • Definitions
  • Statutory requirements
  • Good manufacturing practices for food, drugs, biologics, and devices including IVDs
  • Regulatory requirements
  • Investigational new drug application (IND) and investigational device exemption (IDE)
  • Differences between cosmetics and medical devices
  • Common non-compliance issues and consequences
  • FDA enforcement actions: recent cases
  • Best practices: dos and don’ts
  • PASS-IT suggestions and recommendations

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone interested in the FDA regulatory pathways for new drugs and generics

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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