Aseptic manufacturing is a technique used to produce food or pharmaceutical products that don't require refrigeration. Following sterilization by exposure to heat, products are packaged into sterile containers. The entire packing procedure is also done under sterile conditions. Examples of foods commonly produced using aseptic manufacturing include tomato sauce, salad dressing, and fruit juices.
Date: November 17, 2021 Time: 11:00am (PDT), 2:00pm (EDT) The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it ca...
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: 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 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
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...
Over the past 25 years surgically dependent animal models have expanded from a small, almost niche area in pharmaceutical research to an important component of most research portfolios. In t...
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 ...
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...
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, ...
Dr. Johannes van der Loo will cover the vital role viral vectors play in today's gene research, as well as the use of ultracentrifugation to produce these key delivery systems.
Learnin...
Date: November 17, 2021 Time: 11:00am (PDT), 2:00pm (EDT) The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it ca...
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: 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 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
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...
Over the past 25 years surgically dependent animal models have expanded from a small, almost niche area in pharmaceutical research to an important component of most research portfolios. In t...
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 ...
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...
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, ...
Dr. Johannes van der Loo will cover the vital role viral vectors play in today's gene research, as well as the use of ultracentrifugation to produce these key delivery systems.
Learnin...
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