Quality Risk Management for Pharmaceuticals and Medical Device Industry

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

How to Prevent Common Pitfalls in Quality Risk Management

Get familiar with best practices for quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and biologics) by attending this informative audio session by expert Dr. David Lim. This 60-minute session will cover how quality risk management can be effectively integrated into a quality system (QS) in the pharmaceutical industry.

David will help you understand the risk management principles, tools, methods and processes applicable to the pharmaceutical industry. He will guide you through the details of how to implement the holistic and systemic risk management for drugs, biosimilars and biologics.

Plus, you will know how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.

Areas To Be Covered in this Seminar:

  • Applicable Laws and Regulations
  • Key definitions
  • Risk Management (RM) Process – Systematic and Integrated
  • RM principles
  • Risk management tools and methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
  • Risk ranking
  • Know how to facilitate Quality Risk Management
  • Identify the common mistakes and how to prevent common pitfalls
  • Risk control measures
  • Risk communication – how
  • Insights on RM applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control
  • How to do RM right without wasting resources
  • Practical aspects (value) of risk management
  • Find out the relationship with other quality subsystems
  • How to implement RM in an efficient and effective manner
  • Speaker’s practical PASS-IT guide

Get answers to your questions in Q&A session by the speaker to help you with the doubts and queries you may have.

Who should attend:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Complainant Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors
  • Anyone interested in the topic

Order Below or Call 1-866-458-2965 Today

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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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