This fundamental online course will help you understand the “why” what,” and “how to use” the ISPE Baseline® Guide, Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP). Risk-MaPP provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross-contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this information is an essential tool for you. At the conclusion of this course, participants will be able to:
- Understand the Risk-MaPP concepts.
- Identify the routes for cross contamination.
- Introduce the Logic Diagram.
- Understand the Risk Management process.
- Understand the regulatory requirements.
Attendance suggested for:
- Anyone dealing with multi-product facilities especially QA, Toxicologists, EH&S professionals, Engineers, Operations, Cleaning Validation, Project Managers, Regulators/ Inspectors
- NOTE: This course will expand upon some basic concepts in the following areas so attendees should be familiar with the basics prior to attending this session
- Containment basics and the use of operator exposure limits
- Setting cleaning limits (note this session will not discuss cleaning procedures, processes, etc)
Stephanie Wilkins, PE, Lean Six Sigma Green Belt, has over 30 years of professional experience in project management, risk management, engineering and validation solutions for the pharmaceutical and biotech industry including research, development, and pilot plant and manufacturing facilities. She is president of PharmaConsult US, Inc, which provides cross-contamination and containment consulting to the pharmaceutical industry. Wilkins, a member of ISPE since 1993 is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team and was a member of the ISPE International Board of Directors. Wilkins is an ISPE trainer for Managing Cross Contamination and Risk-MaPP Principles. Wilkins also is a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE. Wilkins graduated from the Pennsylvania State University with a Bachelor of Architectural Engineering.