Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring? |
What should I look for on the ISO 21501-4 calibration certificate? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What should I look for on the ISO 21501-4 calibration certificate? |
Where can I learn more about Analyte Specific Reagents (ASRs)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Where can I learn more about Analyte Specific Reagents (ASRs)? |
What aspects have to be considered while manufacturing under cGMP? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects have to be considered while manufacturing under cGMP? |
Why is Beckman Coulter offering ASRs outside the U.S.? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why is Beckman Coulter offering ASRs outside the U.S.? |
What aspects of the ASR regulation ensure consistency of the product? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the ASR regulation ensure consistency of the product? |
What does Beckman Coulter do to ensure the ASR product quality? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does Beckman Coulter do to ensure the ASR product quality? |
What are the benefits of cGMP Manufacturing? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the benefits of cGMP Manufacturing? |
What are the requirements for calibration certificates of test equipment? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the requirements for calibration certificates of test equipment? |
Do EU GMP or cGMP guidelines require the use of a specific particle counter for air particle cleanliness classification and monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Do EU GMP or cGMP guidelines require the use of a specific particle counter for air particle cleanliness classification and monitoring? |
What are the cGMP requirements for the organization and the personnel? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for the organization and the personnel? |
What are the cGMP requirements for equipment? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for equipment? |
What are the cGMP requirements for production process and control? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for production process and control? |
What are the cGMP requirements for raw material control? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for raw material control? |
What are the cGMP requirements for the laboratory? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for the laboratory? |
What are the cGMP requirements for warehousing? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for warehousing? |
Should I anticipate changes on my product specifications and performance post-IVDR? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Should I anticipate changes on my product specifications and performance post-IVDR? |
A CRO relies solely on paper-based record keeping citing fears of a data breach by a competitor. Is cleanroom data from this CRO submissible to the FDA? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]A CRO relies solely on paper-based record keeping citing fears of a data breach by a competitor. Is cleanroom data from this CRO submissible to the FDA? |
What aspects of the regulation ensure consistency of the product? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the regulation ensure consistency of the product? |
What does the FDA mean by ‘contemporaneously’? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does the FDA mean by ‘contemporaneously’? |
What is an audit trail and how to do I create one? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is an audit trail and how to do I create one? |
What is the difference between cGMP and GPM? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is the difference between cGMP and GPM? |
Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11? |
Are all cleanroom records required to be maintained in electronic format? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are all cleanroom records required to be maintained in electronic format? |
What is flow rate and why is it important for instrument calibration and measurement? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is flow rate and why is it important for instrument calibration and measurement? |
What file format is preferred for electronic records maintenance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What file format is preferred for electronic records maintenance? |
Are open systems ever permitted for GXP cleanroom monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are open systems ever permitted for GXP cleanroom monitoring? |
Are there impacts to periodic 14644-1 classification and re-classification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are there impacts to periodic 14644-1 classification and re-classification? |
What elements are tested as part of an ISO 21501 calibration? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What elements are tested as part of an ISO 21501 calibration? |
How does the ISO 21501-4 calibration standard improve compliance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How does the ISO 21501-4 calibration standard improve compliance? |
Почему силиконовое масло может быть проблемой? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Почему силиконовое масло может быть проблемой? |
Does the IVDR have implications for individual clinical laboratories? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Does the IVDR have implications for individual clinical laboratories? |
Will additional IVDR requirements limit the release of new CE-marked products in the future? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Will additional IVDR requirements limit the release of new CE-marked products in the future? |
What are the key changes to sampling, classification and reclassification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the key changes to sampling, classification and reclassification? |
What are my options for determining a change in my liquid particle counter’s operating characteristics? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are my options for determining a change in my liquid particle counter’s operating characteristics? |
Какие основные разделы содержит глава <1787> Фарм. США (USP <787>)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие основные разделы содержит глава <1787> Фарм. США (USP <787>)? |
What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? |
How does 14644-1 address nanoscale particles? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How does 14644-1 address nanoscale particles? |
What is the National Institute of Standards and Technology (NIST)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is the National Institute of Standards and Technology (NIST)? |
What are NIST (National Institute of Standards and Technology) traceable standards? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are NIST (National Institute of Standards and Technology) traceable standards? |
Do you anticipate the obsolescence of selected CE-marked products? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Do you anticipate the obsolescence of selected CE-marked products? |
Are offsite databases preferred over onsite databases? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are offsite databases preferred over onsite databases? |
Что представляют собой парентеральные лекарственные препараты? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Что представляют собой парентеральные лекарственные препараты? |
How are particle count measurements taken? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How are particle count measurements taken? |
Where can I find guidance for proper calibration of my air and/or liquid particle counter? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Where can I find guidance for proper calibration of my air and/or liquid particle counter? |
Why is counting efficiency checked at each calibration interval? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why is counting efficiency checked at each calibration interval? |
How are ‘particles of interest’ measured in cleanroom and controlled processing environments? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How are ‘particles of interest’ measured in cleanroom and controlled processing environments? |
What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring? |
Какие трудности связны с белковыми лекарственными формами? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие трудности связны с белковыми лекарственными формами? |
Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц? |
What is a “risk-based approach” to 21 CFR 11 compliance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a “risk-based approach” to 21 CFR 11 compliance? |
Is it possible to check on the status of hydraulic fluids in an active system? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Is it possible to check on the status of hydraulic fluids in an active system? |
What is a threshold noise level and how is it determined? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a threshold noise level and how is it determined? |
Какие аспекты охватывает глава <1787> Фарм. США (USP <1787>)и чем она отличается от главы <787> Фарм. США (USP <787>)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие аспекты охватывает глава <1787> Фарм. США (USP <1787>)и чем она отличается от главы <787> Фарм. США (USP <787>)? |
What aspects of the cleanroom environmental monitoring workflow must be validated? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the cleanroom environmental monitoring workflow must be validated? |
Why can silicone oil be a problem? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why can silicone oil be a problem? |
Что представляют собой продукты вымывания? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Что представляют собой продукты вымывания? |
What is coincidence error and how is it determined? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is coincidence error and how is it determined? |
What is an Analyte Specific Reagent (ASR)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is an Analyte Specific Reagent (ASR)? |
What is cGMP? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is cGMP? |
What is a consensus standard? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a consensus standard? |
What is ISO 11171? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is ISO 11171? |
What is SRM 2806? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is SRM 2806? |
When can we expect an update to Part 11? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]When can we expect an update to Part 11? |
What are the cGMP requirements for buildings and facilities? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for buildings and facilities? |
What are the cGMP requirements for documentation? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for documentation? |