Overview

Best Practices for Quality Risk Management for the

Pharmaceutical Industry.

Date: Tuesday, June 30th, 2015 || Time: 01:00 PM EDT | 10:00 AM PST

Duration: 60 Minutes || Course Level: Intermediate

'Live' Webinar by Dr. David Lim

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 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

Register Now

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 Speakers Practical PASS-IT Guide Learning objective 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

CEOs

VPs

Compliance Officers

Attorneys

Clinical Affairs Personnel

Other Interested Parties

Speaker profile

JDr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim frequently presents global

regulatory and quality compliance topics including 510(k) and PMAs in

various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA

templates ready for use compliant with e-Copy and RTA policy. View More