A cleanroom is a space in which the environmental factors including temperature and air flow are controlled and pollutants like dust, microbes, and airborne particles are filtered out. Cleanrooms have strict requirements as to what materials can be brought into the controlled environment and all people entering the room must adhere to guidelines for personal protective equipment. Cleanrooms are maintained to manufacturer products such as pharmaceuticals and medical equipment, which could be harmed by exposure to unexpected particles.
Customizing biosafety cabinets to fit a specific application has become a new trend in biosafety. The ability to get a tailor-made cabinet can create a lot of opportunities for your lab, but...
CGX10 Cell Isolation System: Introduction, Utility, and Assessment in a GMP-grade Environment for Multiparametric Cell Sorting A future of long-term, minimally toxic immunotherapy personaliz...
Date: July 28, 2021 Time: 10:00am (PDT), 1:00pm (EDT) Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points...
DATE: May 27, 2021 TIME: 11:00am PDT A revised version of the USP chapter on Total Organic Carbon (TOC) USP<643> was published recently and will become official on 1 st May 2021. This...
DATE: April 28, 2021 TIME: 11:00am PDT A revised version of the USP chapter on Total Organic Carbon (TOC) USP<643> was published recently and will become official on 1 st May 2021. Thi...
DATE: February 24, 2021 TIME: 10am PST Automated lab instruments such as liquid handlers and cell sorters are increasingly common in all types of laboratories, driving fast results for labor...
DATE: December 14, 2020 TIME: 10:00am PST USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014 and provides specific guida...
DATE: October 23, 2020 TIME: 07:00am PDT, 10:00am EDT The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemen...
DATE: September 09, 2020 TIME: 10:00am PDT, 1:00pm EDT The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advic...
DATE: August 12, 2020 TIME: 10:00am PT Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, man...
DATE: November 5, 2019TIME: 8:00am PSTThe International Committee for Harmonisation issued their recommendations on validating an analytical instrument, ICH Q2, to support users of a...
A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
DATE: December 19, 2017TIME: 8:00 AM PT, 11:00 AM ETIn its chapter on TOC for WFI and PW, the European Pharmacopoeia calls for complete TOC oxidation. This webinar discusses the i...
DATE: November 28th, 2017TIME: 6:00AM PT, 9:00AM ETThe work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation ch...
DATE: October 31st, 2017TIME: 8:00AM PT, 11:00AM ETThis webinar discusses typical sources of water system TOC and conductivity excursions in pharmaceutical water systems a...
DATE: October 4th, 2017
TIME: 6:00AM PT, 9:00AM ET
The new revision of the European Pharmacopoeia chapter on WFI now permits the generation of WFI using double-pass osmosis ...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
April 14, 2016, 7:00am PT, 10:00am ET, 2:00pm GMT
Whether cells are being used to manufacture a therapeutic drug product or for pharmacology, measuring the cell viability and concentration...
February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT
This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 ...
October 7, 2015, 8:00am PT, 11:00am ET, 3:00pm GMT
There are many laboratory Total Organic Carbon (TOC) analyzers available, most of which appear to be suitable for pharmaceutical QC use, ...
Customizing biosafety cabinets to fit a specific application has become a new trend in biosafety. The ability to get a tailor-made cabinet can create a lot of opportunities for your lab, but...
CGX10 Cell Isolation System: Introduction, Utility, and Assessment in a GMP-grade Environment for Multiparametric Cell Sorting A future of long-term, minimally toxic immunotherapy personaliz...
Date: July 28, 2021 Time: 10:00am (PDT), 1:00pm (EDT) Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points...
DATE: May 27, 2021 TIME: 11:00am PDT A revised version of the USP chapter on Total Organic Carbon (TOC) USP<643> was published recently and will become official on 1 st May 2021. This...
DATE: April 28, 2021 TIME: 11:00am PDT A revised version of the USP chapter on Total Organic Carbon (TOC) USP<643> was published recently and will become official on 1 st May 2021. Thi...
DATE: February 24, 2021 TIME: 10am PST Automated lab instruments such as liquid handlers and cell sorters are increasingly common in all types of laboratories, driving fast results for labor...
DATE: December 14, 2020 TIME: 10:00am PST USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014 and provides specific guida...
DATE: October 23, 2020 TIME: 07:00am PDT, 10:00am EDT The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemen...
DATE: September 09, 2020 TIME: 10:00am PDT, 1:00pm EDT The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advic...
DATE: August 12, 2020 TIME: 10:00am PT Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, man...
DATE: November 5, 2019TIME: 8:00am PSTThe International Committee for Harmonisation issued their recommendations on validating an analytical instrument, ICH Q2, to support users of a...
A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
DATE: December 19, 2017TIME: 8:00 AM PT, 11:00 AM ETIn its chapter on TOC for WFI and PW, the European Pharmacopoeia calls for complete TOC oxidation. This webinar discusses the i...
DATE: November 28th, 2017TIME: 6:00AM PT, 9:00AM ETThe work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation ch...
DATE: October 31st, 2017TIME: 8:00AM PT, 11:00AM ETThis webinar discusses typical sources of water system TOC and conductivity excursions in pharmaceutical water systems a...
DATE: October 4th, 2017
TIME: 6:00AM PT, 9:00AM ET
The new revision of the European Pharmacopoeia chapter on WFI now permits the generation of WFI using double-pass osmosis ...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
April 14, 2016, 7:00am PT, 10:00am ET, 2:00pm GMT
Whether cells are being used to manufacture a therapeutic drug product or for pharmacology, measuring the cell viability and concentration...
February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT
This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 ...
October 7, 2015, 8:00am PT, 11:00am ET, 3:00pm GMT
There are many laboratory Total Organic Carbon (TOC) analyzers available, most of which appear to be suitable for pharmaceutical QC use, ...