Critical Elements Of Quality Risk Management Relating to FDA Compliance

This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.

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.

Areas Covered in the Session :

• 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 Should Attend:

This online training will benefit professionals in medical device, pharmaceutical, human tissue, and biotechnology industries, functioning in/as:

• Quality Departments
• Manufacturing Departments
• R&D Departments
• Engineering Departments
• Chemists
• Scientists
• Formulators
• Documentation specialists
• Auditors
• Technicians

Course Director: DANIELLE DELUCY ‎

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle 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. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at 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 to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.