Compliance Trainings, Online
2015-05-29
Description : This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable to pharmaceutical industry (drugs, biosimilars, and biologics) as well as medical device industry. 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, biologics and medical devices. Areas Covered in the Session : Laws and Regulations Key Definitions Risk Management (RM) Principles Risk Management Process – Systematic and Integrated 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 Interfacing and Relationship with Other Quality Subsystems Best Practices for Implementing Quality Risk Management in an Efficient and Effective Manner. Speaker’s Practical PASS-IT Recommendations Who Will Benefit: CEOs VPs Compliance Officers Attorneys Complainant Managers Managers (RA, QA/QC, CA) Consultants Contractors and Subcontractors Anyone interested in the topic
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