Course Description

The goal of risk management in our industry is to provide a mechanism for value-added, logical, unbiased and scientific evaluation of processes and products with the focus on quality, safety, efficacy and purity. Assessing and managing risk provides a basis for understanding process development activities, writing and executing targeted and compliant validation plans, implementing value-added routine monitoring and performing proficient failure investigations. This course provides participants with an understanding of the GMP-compliant application of various risk assessment and management techniques. Participants in this course will be part of a team that will actively apply the principles of risk analysis to the start up of a new parenteral facility. With facility blueprints, flows and product specifications in hand, we will use FMEA, HACCP, Fault Tree Analysis, and Environmental Risk techniques to construct and implement a Master Validation Plan for our new product, set up a routine monitoring program and mitigate “excursions” that happen during start up.

Course Instructors
This course is taught by Karen Z. McCullough and Anne Marie Dixon. Karen Z. McCullough is the Director of Quality Operations at Roche Molecular Systems in Branchburg, NJ. She is acknowledged as a worldwide expert in the field of bacterial endotoxin testing (LAL). She is a Founder, Charter Member and Steering Commttee Member for the LAL Users Group. Ms. McCullough's interest is in the convergence of science and compliance in the application of the principles and practices of cGMP to pharmaceutical microbiology. Ms. McCullough holds a B.S. degree in Bacteriology from Rutgers University and a M.S. degree in Molecular Biology from the University of Oregon. She has been involved in LAL testing and pharmaceutical microbiology for over 30 years.

Anne Marie Dixon is the Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.

She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization.

Anne Marie was the first woman to be elected President of the IEST and was appointed to the position of FELLOW in 1998. She is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor. She is the head of the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments.

Learning Objectives

This course will provide participants with a “hands-on” understanding of the business and compliance benefits of risk analysis. Upon completion, attendees will have an understanding of the types of tools available for risk analysis, the benefits of risk analysis techniques in a GMP environment and the application of these techniques to real situations encountered in the manufacture of parenteral products.

Course Outline

• Risk is Not a Four-Letter Word
  • Compliance and business basics for understanding risk analysis
  • FDA, ISO, ICH thoughts on risk analysis
• Hazard Analysis and Critical Control Point Analysis (HACCP)
  • Origins of HACCP
  • Seven Steps to HACCP
  • Workshop: process analysis using HACCP – constructing a master validation plan for a new product
• Failure Modes and Effect Analysis (FMEA)
  • Basics of FMEA: nomenclature, structure and thought processes
  • Projecting failure through FMEA
  • Workshop: HVAC PQ failure investigation - FMEA
• Environmental Risk: Setting Up an Environmental Monitoring Program for the New Facility
  • Control vs. Monitoring: EM Basics
  • Logic and framework for environmental risk analysis
  • Workshop: Using an environmental risk assessment to determine value added routine monitoring
• Fault Tree Analysis and Fishbone Analysis for the Investigation of Failures
  • Fault tree analysis and fishbone analysis to predict failure
  • Workshop: Use of fault tree analysis/fishbone analysis to investigate a media fill failure