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.
- Applicable statute(s), Regulations, and Definitions
- Risk Management (RM) Process – Systematic and Integrated
- RM Principles
- Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
- Risk Ranking
- How to Facilitate Quality Risk Management
- Common Mistakes and How to Prevent Common Pitfalls
- Risk Control Measures
- Risk Communication – How
- RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control.
- Doing RM Right Without Wasting Resources
- Practical Aspects (Value) of Risk Management
- Relationship with Other Quality Subsystems
- Implementing RM in an Efficient and Effective Manner.
- Speaker’s Practical Guide
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 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.