Process Validation for Medical Devices

The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.

Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this course, participants will be able to methodically plan and conduct a process validation.

Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products.

Issues to be covered include:

• Learn how poor validation procedures and practices can lead to regulatory actions from regulators
• Assurance of product quality derived from a compliant validation program
• Learn how to improve process system knowledge and understanding
• Learn methods for developing process validations and best practices
• Understand the scope of regulations governing process validation and identify gaps
• Develop a plan to rectify existing validation plans, protocols and reports
• Learn how to implement and deploy a master validation plan

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

Shannon Goodson has over 20 years of process and project engineering experience, with over 15 years in the Pharmaceutical and Biotech industry in areas including biotechnology, medical devices, oral solid dose, liquid dosage and primary/secondary packaging. Experience has included Process and Project engineering management in manufacturing and packaging as well as in Operations Supervision. Her experience has also included several years of design consulting engineering, where she focused her attention on Oral Solid Dose, Containment and Potent Compound projects.

Currently, Ms. Goodson is a Process Validation Manager at CSA-Soliance. Duties include managing Validation projects for equipment, facilities and processes, incorporating a Risk-Based approach. Previously, she was a Senior Process Engineer with Cytovance Biologics, as well as with Astellas Pharma Technologies. She was also Process Engineer at CRB Consulting Engineers where her clients included GSK, Merck, Covidien, Novartis and others.

Her specialties include: project management, process engineering, hands-on manufacturing experience, lean manufacturing, equipment trouble-shooting, document writing (Specifications, SOP, Batch Record, Validation), Biotechnology, Medical Devices, Liquid manufacturing and packaging, Aerosol manufacturing and packaging and Oral Solid Dose manufacturing and packaging.

Ms. Goodson earned her Bachelor of Science degree in Chemical Engineering at the University of Tulsa and holds a Master of Engineering Management degree from Washington University in St. Louis.