Plastics Workshops and Seminars
Process Validation for Medical Injection Molding
Instructors: James Ladtkow
WHO SHOULD ATTEND:
Process technicians, engineers, and managers involved in molding plastic components for the medical market should attend this one-day seminar to improve their process validation methods. This seminar is also valuable to anyone who would like to understand the requirements for molding in an FDA-regulated environment.
EDUCATIONAL GOALS:
This seminar will cover the basic requirements for process validation in an FDA-regulated environment. Medical device regulations and QSRs (formerly GMPs) will be explored, including their application to injection molding. Specifically, how the IQ, OQ, and PQ concepts are applied to molding processes will be reviewed. The application of DOE and statistical process control will also be discussed, including how these tools can assist the molder with showing good validation to their customers or regulators. The seminar consists primarily of an interactive presentation with numerous examples of validation do's and don'ts. Case studies will be used for participants to test their knowledge of the validation principles. At the end of the day, each student should be able to apply the concepts of FDA process validation to their own processes.
SEMINAR OUTLINE:
1. Requirements for a Validated Process
2. When is Validation Needed?
3. What the FDA Expects to See
4. Who Needs to Follow the Regulations?
5. What are IQ, OQ and PQ?
6. When Does the IQ Start?
- What is included in the IQ?
- How does DOE fit in to the OQ?
- Where does SPC fit in this process?
7. How to Know a Validated Process when You See It
8. How to Apply these Concepts when You Get Home