Description

This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable for the 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.

Areas To Be Covered in this Webinar:

• 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
• 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 PASS-IT Guide

Who will benefit:

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