Cleanrooms
Cleanrooms: A cleanroom or clean room is a facility ordinarily utilized as a part of specialized industrial production or scientific research, including the manufacture of pharmaceutical items and microprocessors. Cleanrooms are designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. Cleanrooms typically have an cleanliness level quanitified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 particles for each cubic meter in the size range 0.5 μm and bigger in measurement, equivalent to an ISO 9 cleanroom, while by comparison an ISO 1 cleanroom permits no particles in that size range and just 12 particles for each cubic meter of 0.3 μm and smaller.
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DEC 14, 2020 10:00 AM PSTAdd to Calendar Select one of the following:
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DEC 14, 2020 10:00 AM PSTAdd to Calendar Select one of the following:
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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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesOCT 23, 2020 7:00 AM PDTC.E. CREDITS
OCT 23, 2020 7:00 AM PDTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesSEP 09, 2020 10:00 AM PDTC.E. CREDITS
SEP 09, 2020 10:00 AM PDTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesAUG 12, 2020 10:00 AM PDTC.E. CREDITS
AUG 12, 2020 10:00 AM PDTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesNOV 05, 2019 8:00 AM PSTC.E. CREDITS
NOV 05, 2019 8:00 AM PSTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesAPR 04, 2018 8:00 AM PDT
APR 04, 2018 8:00 AM PDTA 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesFEB 21, 2018 8:00 AM PST
FEB 21, 2018 8:00 AM PSTDATE: TIME: ...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesDEC 19, 2017 8:00 AM PST
DEC 19, 2017 8:00 AM PSTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesNOV 28, 2017 6:00 AM PST
NOV 28, 2017 6:00 AM PSTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesOCT 31, 2017 8:00 AM PDT
OCT 31, 2017 8:00 AM PDTDATE: 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...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesOCT 04, 2017 6:00 AM PDT
OCT 04, 2017 6:00 AM PDTDATE: 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 ...Speaker: Tony HarrisonSponsored By: Beckman Coulter Life SciencesSEP 05, 2017 8:00 AM PDT
SEP 05, 2017 8:00 AM PDTDATE: 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...Speaker: Tony HarrisonPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life SciencesJUL 19, 2017 7:00 AM PDT
JUL 19, 2017 7:00 AM PDTDATE: 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...Speaker: Tony HarrisonPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life SciencesSEP 08, 2016 8:00 AM PDT
SEP 08, 2016 8:00 AM PDTDATE: 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 ...Speaker: Tony HarrisonPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life SciencesJUL 13, 2016 8:00 AM PDT
JUL 13, 2016 8:00 AM PDTJuly 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...Speaker: Joe GecseyPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life SciencesAPR 14, 2016 7:00 AM PDT
APR 14, 2016 7:00 AM PDTApril 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...Speaker: Tony HarrisonPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life SciencesFEB 25, 2016 9:00 AM PST
FEB 25, 2016 9:00 AM PSTFebruary 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 ...Speaker: Joe GecseyPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life SciencesOCT 07, 2015 8:00 AM PDT
OCT 07, 2015 8:00 AM PDTOctober 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, ...Speaker: Tony HarrisonPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life SciencesAPR 08, 2015 7:00 AM PDT
APR 08, 2015 7:00 AM PDTThis educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has rece...Speaker: Joe GecseyPresented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life Sciences
DEC 14, 2020
10:00 AM PST
Add to Calendar
Select one of the following:
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iCal
Google Calendar
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DEC 14, 2020
10:00 AM PST
Add to Calendar
Select one of the following:
iCal
Google Calendar
Outlook Calendar
Yahoo Calendar
iCal
Google Calendar
Outlook Calendar
Yahoo Calendar
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
OCT 23, 2020
7:00 AM PDT
C.E. CREDITS
OCT 23, 2020
7:00 AM PDT
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
SEP 09, 2020
10:00 AM PDT
C.E. CREDITS
SEP 09, 2020
10:00 AM PDT
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
AUG 12, 2020
10:00 AM PDT
C.E. CREDITS
AUG 12, 2020
10:00 AM PDT
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
NOV 05, 2019
8:00 AM PST
C.E. CREDITS
NOV 05, 2019
8:00 AM PST
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
APR 04, 2018
8:00 AM PDT
APR 04, 2018
8:00 AM PDT
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
FEB 21, 2018
8:00 AM PST
FEB 21, 2018
8:00 AM PST
DATE: TIME: ...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
DEC 19, 2017
8:00 AM PST
DEC 19, 2017
8:00 AM PST
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
NOV 28, 2017
6:00 AM PST
NOV 28, 2017
6:00 AM PST
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
OCT 31, 2017
8:00 AM PDT
OCT 31, 2017
8:00 AM PDT
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...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
OCT 04, 2017
6:00 AM PDT
OCT 04, 2017
6:00 AM PDT
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 ...
Speaker:
Tony Harrison
Sponsored By: Beckman Coulter Life Sciences
SEP 05, 2017
8:00 AM PDT
SEP 05, 2017
8:00 AM PDT
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...
Speaker:
Tony Harrison
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences
JUL 19, 2017
7:00 AM PDT
JUL 19, 2017
7:00 AM PDT
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...
Speaker:
Tony Harrison
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences
SEP 08, 2016
8:00 AM PDT
SEP 08, 2016
8:00 AM PDT
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 ...
Speaker:
Tony Harrison
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
JUL 13, 2016
8:00 AM PDT
JUL 13, 2016
8:00 AM PDT
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...
Speaker:
Joe Gecsey
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
APR 14, 2016
7:00 AM PDT
APR 14, 2016
7:00 AM PDT
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...
Speaker:
Tony Harrison
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
FEB 25, 2016
9:00 AM PST
FEB 25, 2016
9:00 AM PST
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 ...
Speaker:
Joe Gecsey
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
OCT 07, 2015
8:00 AM PDT
OCT 07, 2015
8:00 AM PDT
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, ...
Speaker:
Tony Harrison
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
APR 08, 2015
7:00 AM PDT
APR 08, 2015
7:00 AM PDT
This educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has rece...
Speaker:
Joe Gecsey
Presented at: Beckman Coulter Life Sciences Virtual Trade ShowSponsored By: Beckman Coulter Life Sciences,
Beckman Coulter Life Sciences
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