1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
A 3-Day Intensive Continuing Education Course 1.65 CEUs)
About this course
To prevent product contamination manufacturers need to employ cleanroom environments. As the cost of cleanroom operations increases, management of this space becomes a critical task. The state of cleanliness can only be maintained through a deliberate program of training, personnel monitoring, proper gowning, cleaning and sanitization, process controls and environmental monitoring. Finding root causes for CAPAs and Investigations will be addressed and case study work will be included in this course.
Process simulation (media fills) is a difficult and often complex issue in today’s fill/finish, bulk manufacturing and cell operations environments. The development of this requirement will be discussed in view of the new regulatory changes in the US and Europe. Environmental monitoring during validation and the selection of sites for routine monitoring will be discussed in great detail. An update of all the new standards will be included with comparisons to existing standards.
At the end of this course you will have a thorough understanding of cleanroom operation and management.
if you are involved in the specifications, design,
operations, auditing and monitoring of a cleanroom or controlled environment.
if you belong to Manufacturing, Quality Assurance, Quality
Control, Engineering or Maintenance departments.
if you are a contract cleaning company or a cleanroom
supplier.
if you need an update in the new requirements of cleanroom
operations
if you simply need to know more about contamination control
and investigations
You will benefit from this course -
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