FDA 483 Observations related to Smoke Studies
ฝัง
- เผยแพร่เมื่อ 30 เม.ย. 2020
- Why should you attend - Why is it important to learn about the topic
The multitude of FDA 483 observations and warning letters citing data integrity for; environmental monitoring, media fill and product sterility testing data begins with poorly executed airflow visualization studies (smoke studies). The increased scrutiny by regulatory agencies regarding smoke studies is indicative of regulator’s lack of confidence in outdated approaches to contamination control as well as concerns over aging facilities and obsolesced systems.
The “c” in cGMP stands for current and per the FDA; “systems and equipment that may have been top of the line to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.”
This training will address the common errors and misunderstanding related to smoke studies, specifically addressing updated regulator thinking.
Areas Covered in the Session:
• The science and history of airflow visualization in cleanrooms
• Updated regulatory perspective on smoke studies
• Case studies and 483 observations related to smoke studies
• Common observations,
• Myths and mistakes related to “in-situ air pattern analysis”
• Common mistakes made that lead to 483 observations
• Data integrity related smoke studies; a common phenomenon
Instructor Profile:
Morgan Polen: Cleanroom, Particulate and Airflow Expert at Microrite, Inc.
Morgan Polen is a subject matter expert on contamination control, airflow visualization and particle monitoring in cleanrooms with over 30 Years of industry experience’.
He is a member of the ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments) and a board member of IEST and has been instrumental in drafting and editing ISO 14644 and other cleanroom related standards. He has extensive experience in working on cleanroom projects in the United States, Canada, Mexico, Germany, Malaysia, Taiwan, South Korea, Singapore, Thailand, China, Philippines, India and Turkey and is a valuable resource in addressing contamination.
