Training Courses from 2012


Continuing education training courses are available either as stand-alone classes, combined into certificate programs, or as part of a four-day education passport. Registration includes: Admission ticket to the course(s) registered for • Unlimited admission to Working Group meetings

*A Certificate in the ISO Series is awarded for attendance in all three courses marked with an asterisk (*).

Attend four full days of courses at a substantial discount – Register for the Continuing Education Passport. With the Passport you can earn 2.4 CEUs and save up to $395 on courses compared with the individual course fees.

Developing SOPs for Your Cleanroom
.6 CEUs
Instructor: Anne Marie Dixon
Sponsored by Sterile Environment Technologies, Inc.

This hands-on workshop will train students how to develop Standard Operating Procedures (SOPs) based on IEST-RP-CC018: Cleanroom Housekeeping—Operating and Monitoring Procedures and ISO 14644-5: Cleanrooms and associated controlled Environments—Part 5: Operations. Registrants will receive copies of these documents, which will be used as the basis for the development of SOPs for Cleaning and Sanitization and Personnel Practices—Protocols and Gowning.

How to Comply with Food Safety Law (FSMA) Using Cleanroom Technology
.6 CEUs
Instructors: Jan Eudy, Stacy Street, and Shawn Windley
Sponsored by Cintas Corporation

Since the Food Safety Modernization Act (FSMA) was passed in January 2011, FDA has stepped up its inspection and enforcement program. FSMA regulations aim to ensure the safety of the US food supply to reduce food-borne illnesses. The infiltration of pathogens into the food production and packaging process can be controlled through a comprehensive prevention program that targets the environment in which these activities are performed. Principles of cleanroom technology, long used in manufacturing for the critical electronic, medical device, and pharmaceutical industries, can effectively be adopted by processors of food products. This course provides a basic understanding of these principles so attendees can begin to understand how to control their environment to prevent the generation and transfer of such contamination to food products.


Understanding the ISO Series*
.3 CEUs
Instructor: Robert Mielke
Sponsored by TSS, Inc.

This half-day course presents the ISO/TC 209 Technical Committee to the attendee along with a brief overview of the ISO 14644 series of documents in order to familiarize them with the breadth of the work being undertaken by the committee. A substantial portion of the workshop will cover the requirements of the ISO 14644-2:2000 Standard, ISO 14644 Cleanrooms and associated controlled environments—Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1, in its entirety and will also include a discussion on possible major changes to the document in the future.

Testing to Determine the Classification of Air Cleanliness*
.3 CEUs
Instructor: Robert Mielke
Sponsored by TSS, Inc.

This half-day course covers the requirements of the linchpin document of the ISO 14644 series, ISO 14644 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness. The workshop will cover all aspects of the current (1999) document and why certain provisions are in the document. The course will also cover the status of the latest proposed revisions to this document, including the proposed statistical method for selecting cleanroom sample locations.


The Practical Application of ISO 14644-3*
.6 CEUs
Instructors: Robert Mielke and Daniel Dennison
Sponsored by TSS, Inc.

This course will explore the practical application of the ISO 14644 series that a certification contractor would use to certify a clean space. The course will include an open forum discussing how to implement the standards, what may or may not work in different types of cleanroom environments, primary equipment used, and a group cleanroom evaluation workshop. Attendees need a calculator for the class. This course includes a copy of ISO 14644 Cleanrooms and associated controlled environments—Part 3: Test Methods.