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Cleanroom Training Courses
16 training items found
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Our experts can train you at your site or organize events and company seminars. Basic training includes: Environmental and personnel monitoring. Cleanroom behavior and best practices. Cleaning and disinfection strategy. Good Distribution Practices (GDP). Microbiological laboratory best practices. Qualification vs. ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Environmental Monitoring Risk/Gap Analysis: Define or review the monitoring sampling points for your environment with a scientific and risk-based ...
by:Clean Air Technologies Ltd. based inRochester, UNITED KINGDOM
The workshops can be integrated in site-specific Quality Managment protocols and tailored to suit individual needs. The content both enhances and reinforces the principles of Bio-Containment, GMP and Cleanroom Design & ...
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors. Total particle contamination is a mixture of nonviable and viable particles. ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Dan Rodier will provide a brief overview of AMC along with the latest technology for efficiently identifying AMC sources in the ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components. Absence of viable and non-viable contamination is considered a critical quality ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
On December 20th, 2017, the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications. During the creation process, the ...
by:Association for the Healthcare Environment (AHE) based inChicago, ILLINOIS (USA)
AHE’s CSCT certification program sets a standard for surgical environmental services technicians responsible for cleaning and disinfecting operating rooms — an intense, fast-paced, high-stakes environment. The program is designed to set a level of expertise for managing pathogens and practicing innovative techniques specific to the operating room. The CSCT certification program offers ...
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO ...
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of products ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This Pharma GMP courseware covers all aspects of good manufacturing practices starting from difference between GLP and GMP, vendor selection, supplier agreements & management, raw material risk management, HVAC, GMP environmental control, pharma compressed air, annual product reviews ,deviation investigations, human error reduction ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
The following training is a pack of 10 best-selling training CDs for the microbiology lab. These courses provide solutions for all critical challenges faced by microbiology lab professionals pertaining to regulations/compliance, best practices, quality, ...