April 14 | 8:00AM
Meeting the New ISO Cleanroom Standards and Changing EU Guidance Workshop
The International Cleanroom Standards (ISO 14644-1 & 2) have been updated, these changes affect the requirements for the classification testing and monitoring of ALL cleanrooms. The classification testing standard has significant changes and includes the requirements for the development of a "Monitoring Plan" based upon risk assessment. How will you comply with these changes? Why Attend?
This program is set up to eliminate the confusion between regulatory requirements, the inspector's expectations, and the changes in ISO standards and upcoming EU Annex 1 changes. FDA Observations, warning letters, and case studies will be used to clarify regulatory expectations for sterile and non-sterile facilities. Location:
4221 Mitchell Ave, St. Joseph, MO 64507
April 14 & 15 | 8:00 a.m. - 5:00 p.m. For more information, please contact Tammy Platt