Critical Elements of Quality Risk Management Relating to FDA Compliance

Why Should You Attend:

This webinar is intended to help participants better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical 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 training session will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, it will help attendees develop and implement a systematic and holistic risk management strategy integrated into the quality system.

Learning Objectives:

• Discuss what is risk management
• Outline the requirements for applying risk management to the quality system
• Discuss how to conduct and implement risk management practices at your firm
• Review communication techniques to highlight the benefits of risk management

Areas Covered in the Webinar:

• What is Risk Management?
• Regulatory Requirements
• Key Definitions
• Exploring Risk Management (RM) Process – Systematic and Integrated
• Reviewing RM Principles
• Risk Management Implementation
• Using Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
• How to Perform Risk Ranking
• How to Facilitate Quality Risk Management
• Common Mistakes and How to Prevent Common Pitfalls
• Implementing Risk Control Measures
• Risk Management Application and Integration
• Risk Communication – How
• RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Testing and Quality Control
• Relationship with Other Quality Systems
• Implementing RM in an Efficient and Effective Manner

Who Will Benefit:

This online training will benefit professionals in medical device, pharmaceutical, human tissue, and biotechnology industries, functioning in departments such as: QA/QC/RA, manufacturing/operations, research and development, and legal. The job functions include:

• Department managers and supervisors
• QA/QC/RA specialists and engineers
• Manufacturing
• R&D engineers
• Chemists
• Scientists
• Formulators
• Documentation specialists
• Auditors
• Technicians

Danielle DeLucy
Associate Director Quality Assurance and Microbiology, MTF

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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