Essential Cleanroom Standards ISO 14644-1 and ISO 14644-2: The Foundations of Contamination Control
The International cleanroom standards, ISO 14644 Parts 1 and 2 are the essential part of any discussion related to cleanrooms and maintaining contamination control. This course will provide technical information and provide case histories related to the understanding and implementation of these important cleanroom standards.
Instructor: Morgan Polen
Morgan Polen is the principal consultant for Microrite. Morgan brings 30 years’ experience working in cleanrooms and is a subject matter expert in particle monitoring. He has been involved with various cleanroom projects working in over 40 countries. With hands on experience in projects ranging from cleanroom design, construction, validation, monitoring program development, particle counter design, and product management for cleanroom related products and systems. Addressing monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and food and beverage manufacturing. He has lectured on particle monitoring and contamination control in North America, South America, Europe, Asia, and the Middle East.
Upcoming training dates:
March 9, 2021
9:30 a.m. - 5 p.m. Central Time
Virtually
Early-bird discount registration ends January 15. Use code EB3ISO21 to save 10%
Online registration closes March 3, 2021
New ISO 14644-3:2019 - Basic Information and Implementation
This course will provide you with detailed information about revisions and general implementation for existing cleanroom testing procedures.
- Comparison between 2005 and 2019 Versions
- Terms and definitions,
- Incorporation with ISO 14644-1:2015,
- Test Procedures,
- Supporting Test Explanations,
- Test Apparatus and Testing details,
- Application Examples,
- Proper Reporting
Instructor: Hasim Solmaz
Hasim Solmaz is General Manager of Lighthouse Worldwide Solutions EMEA Operations. Hasim’s focus is on cleanroom design and management concepts, environmental monitoring systems, pharmaceutical manifacturing and regulatory concerns. Hasim is a founding chair of Cleanroom Technologies Society of Turkey, head of delegates in ISO TC209 “Cleanrooms and associated controlled environments” and expert in ISO TC209 “Cleanrooms and associated controlled environments” Working Group 3 “Cleanroom Test Methods”. Recently appointed as honorary chair of ICCCS, The International Confederation of Contamination Control Societies which is an international community for national society on cleanrooms and contamination control. Hasim is an active member of International Society for Pharmaceutical Engineering (ISPE), Institute of Environmental Sciences and Technology (IEST) and Parenteral Drug Association (PDA). He holds a Bachelor of Science degree with high honors in Atmospheric Science and Meteorological Engineering from Istanbul Technical University.
Upcoming training dates:
March 10, 2021
9:30 a.m. - 5 p.m. Central Time
Virtually
Early-bird discount registration ends January 15. Use code EB3ISO21 to save 10%
Online registration closes March 3, 2021
Universal Cleanroom Operations Guidelines with ISO 14644-5
The ISO 14644-5 Cleanrooms and Associated Controlled Environments – Operations International Standard specifies the basic requirements for cleanroom operations. This course will discuss each Annex in detail and align this information with references to IEST Recommended Practices.
Instructor: Jan Eudy
Jan E. Eudy is a cleanroom/contamination control consultant with over 25 years of industry experience. Jan is a technical resource for cleanroom, food and healthcare reusable garments and consumable products. From 1994 – 2014, Jan implemented and maintained the ISO 9001 based quality management system and ISO registration at all Cintas cleanroom locations and supported validation and sterile services. From 2006 – 2013, Jan implemented and maintained the HACCP risk management program at Cintas industrial laundries. She is a Fellow and President Emeritus of the Institute for Environmental Science and Technology. She is an active member of other professional organizations including the International Dairy Foods Association, Food Processors of Canada, International Association for Food Protection, American Society of Clinical Pathologists, National Registry of Certified Microbiologists, American Society for Microbiology, American Society for Quality, International Society for Pharmaceutical Engineers and Parenteral Drug Association. Jan graduated with a Bachelor of Science degree in Medical Technology from the University of Wisconsin with graduate studies in Medical Microbiology at Creighton University. Jan’s additional qualifications include Registered Medical Technologist and Specialist in Microbiology with ASCP, Registered Microbiologist with NRCM in Consumer Product Testing and Quality Assurance, ISO 9000 Provisional Auditor with RAB(QSA), Certified Quality Auditor with ASQ, Certified HACCP Trainer by the International HACCP Alliance and is ServSafe certified.
Upcoming training dates:
March 11, 2021
9:30 a.m. - 5 p.m. Central Time
Virtually
Early-bird discount registration ends January 15. Use code EB3ISO21 to save 10%
Online registration closes March 3, 2021