September 9, 2019 @ 1:00 PM – 2:00 PM
LIVE Online Seminar (LIVE Webinar)
Global Compliance Seminar
731-Go to GCS (468-6427)

LIVE Online Seminar

Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches

  • Date: September 09, 2019
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to discuss systematic and holistic approaches of quality risk management (QRM) for pharmaceutical industry (drugs, biosimilars, and biologics).

This seminar is further intended to discuss how quality risk management can be effectively integrated into a quality system (QS) in the pharmaceutical industry.

This seminar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.

In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for drugs, biosimilars and biologics.

About the Areas to Be Discussed

  1. Applicable statute(s), Regulations, and Definitions
  2. Risk Management (RM) Process – Systematic and Integrated
  3. RM Principles
  4. Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
  5. Risk Ranking
  6. How to Facilitate Quality Risk Management
  7. Common Mistakes and How to Prevent Common Pitfalls
  8. Risk Control Measures
  9. Risk Communication – How
  10. RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control.
  11. Doing RM Right Without Wasting Resources
  12. Practical Aspects (Value) of Risk Management
  13. Relationship with Other Quality Subsystems
  14. Implementing RM in an Efficient and Effective Manner.
  15. Speaker’s Practical Guide

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 


LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches