Process Validation is a term used to indicate that a process has been subject to such scrutiny that the result of the process can be practically guaranteed. Validation of a process entails demonstrating that, when a process is operated within specified limits, it will consistently meet the requirements established in design and development. More specifically the validation of a process is the mechanism or system used by the manufacturer to plan, obtain data, record data, and interpret data.

This workshop will teach the essential principles of Process Validation. Students will learn how to successfully implement Process Validation into their organizations and about the significant cost savings and improved process control it can deliver to companies. In addition the course will cover potential regulatory requirements for Process Validation.

About The Instructor:
Betty Lane

Betty Lane has over 20 years experience in Medical Device quality assurance and regulatory affairs. She has established or updated quality systems for numerous small and medium sized medical device and diagnostic companies. Her accomplishments enabled these companies to manage their business in compliance with FDA and ISO 13485 requirements, thus enabling worldwide sale of their products. Her background in digital systems engineering, enabled her to facilitate design controls and software validation when they became FDA and industry requirements.

Accomplishments include:

Implementing ISO 13485in 6 months, for several companies Established the quality system for PB Diagnostics (later Behring Diagnostics), and obtained ISO 9001 certification for Instrumentation Laboratories in Lexington, MA, among others Taught courses at Northeastern University, Boston MA, in Regulatory Affairs and cGMP Taught AAMI Quality Systems Regulation and Design Control courses, which provide comprehensive training for both industry and FDA personnel.

Member of the Advisory Board of DQS, Inc.., a world wide RAB accredited ISO 9000/QS9000/AS9000 registrar for over 20 SIC categories Featured in Journeys of Women in Science and Engineering, No Universal Constants, by Susan A. Ambrose, et. al., Temple University Press, 1997. Betty is the founder and President of Be Quality Associates, LLC, a consulting company helping medical device companies implement and improve their quality systems for both business improvement and regulatory compliance. Other services included training, auditing, supplier management and medical device quality system software validation. Betty is active in the local sections of the American Society for Quality including having served on the committee for Boscon, the Boston Chapter’s annual quality conference. Her publications include articles on long-term cardiac monitoring and “A Successful University-based Eight-week Regulatory Affairs Course.” Betty has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is a member of the American Society for Quality, Regulatory Affairs Professional Society, Association for the Advancement of Medical Instrumentation, The Society of Women Engineers, and the Institute of Electrical and Electronic Engineers.