This webinar is intended to help you better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and biologics). The contents of this webinar is also highly applicable to the medical device industry.

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

This webinar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, this webinar 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 webinar, the speaker will guide you through the details of how to implement the systematic and holistic risk management for drugs, biosimilars and biologics.

The speaker will walk you through the best FDA compliant practices.

Why Should You Attend

To get familiar with the FDA compliant risk management plans and practices.

Areas Covered in the Session

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 Testing 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

Learning Objectives

To better understand and establish quality risk management practices.

Who Will Benefit

•  Regulatory Affairs
•  Quality Professionals
•  R&D Professionals
•  Complaint And Risk Management Personnel
•  Consultants
•  Contractors/Subcontractors
•  CEO’s
•  VP’s
•  Compliance Officers
•  Attorneys
•  Clinical Affairs Personnel
•  Other Interested Parties



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