| Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring? | 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? | What should I look for on the ISO 21501-4 calibration certificate? |
| Where can I learn more about Analyte Specific Reagents (ASRs)? | Where can I learn more about Analyte Specific Reagents (ASRs)? |
| What aspects have to be considered while manufacturing under cGMP? | What aspects have to be considered while manufacturing under cGMP? |
| Why is Beckman Coulter offering ASRs outside the U.S.? | Why is Beckman Coulter offering ASRs outside the U.S.? |
| What aspects of the ASR regulation ensure consistency of the product? | What aspects of the ASR regulation ensure consistency of the product? |
| What does Beckman Coulter do to ensure the ASR product quality? | What does Beckman Coulter do to ensure the ASR product quality? |
| What are the benefits of cGMP Manufacturing? | What are the benefits of cGMP Manufacturing? |
| What are the requirements for calibration certificates of test equipment? | 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? {d068caa5-ddce-4673-8182-8bb027e5847b}|{6b81a591-2b23-47f4-8f1e-7df0b29afd77}|{48b794e8-25ab-4428-8c2f-fe4be0b4399f}|{dace6bfd-8fb8-49fa-9877-631632899795}|{2ebc6b45-cfba-4fcc-917d-5b2d5cd218c4}|{3144f8d9-c5c2-421b-85e0-88ac31044bce} | {5a96c3ac-a1e7-41bb-84f0-545bee773a05}|{5140ed78-c4d4-4c98-8cc5-84d01ac9c44c}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? | What are the cGMP requirements for the organization and the personnel? |
| What are the cGMP requirements for equipment? | What are the cGMP requirements for equipment? |
| What are the cGMP requirements for production process and control? | What are the cGMP requirements for production process and control? |
| What are the cGMP requirements for raw material control? | What are the cGMP requirements for raw material control? |
| What are the cGMP requirements for the laboratory? | What are the cGMP requirements for the laboratory? |
| What are the cGMP requirements for warehousing? | What are the cGMP requirements for warehousing? |
| Should I anticipate changes on my product specifications and performance post-IVDR? | {ab74f100-9492-4b5b-bfbb-1a07320b93da}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? | 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? | What aspects of the regulation ensure consistency of the product? |
| What does the FDA mean by ‘contemporaneously’? | What does the FDA mean by ‘contemporaneously’? |
| What is an audit trail and how to do I create one? | What is an audit trail and how to do I create one? |
| What is the difference between cGMP and GPM? | What is the difference between cGMP and GPM? |
| Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11? | 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? | 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? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is flow rate and why is it important for instrument calibration and measurement? |
| What file format is preferred for electronic records maintenance? | What file format is preferred for electronic records maintenance? |
| Are open systems ever permitted for GXP cleanroom monitoring? | Are open systems ever permitted for GXP cleanroom monitoring? |
| Are there impacts to periodic 14644-1 classification and re-classification? | Are there impacts to periodic 14644-1 classification and re-classification? |
| What elements are tested as part of an ISO 21501 calibration? {d068caa5-ddce-4673-8182-8bb027e5847b}|{0940f4ac-7b9b-48d6-984d-f9e2c42532ae}|{6cc809af-8eb6-405f-a5c3-cec8bb4855f6}|{1a085b75-5d0b-4b73-b017-6a63554c648d} | {5a96c3ac-a1e7-41bb-84f0-545bee773a05}What elements are tested as part of an ISO 21501 calibration? |
| How does the ISO 21501-4 calibration standard improve compliance? | How does the ISO 21501-4 calibration standard improve compliance? |
| Why might silicone oil present an issue? | Why might silicone oil present an issue? |
| Does the IVDR have implications for individual clinical laboratories? | {ab74f100-9492-4b5b-bfbb-1a07320b93da}Does the IVDR have implications for individual clinical laboratories? |
| Will additional IVDR requirements limit the release of new CE-marked products in the future? | {ab74f100-9492-4b5b-bfbb-1a07320b93da}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? | 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? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What are my options for determining a change in my liquid particle counter’s operating characteristics? |
| What are the main sections of USP <1787>? | What are the main sections of USP <1787>? |
| What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? | What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? |
| How does 14644-1 address nanoscale particles? | How does 14644-1 address nanoscale particles? |
| What is the National Institute of Standards and Technology (NIST)? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is the National Institute of Standards and Technology (NIST)? |
| What are NIST (National Institute of Standards and Technology) traceable standards? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What are NIST (National Institute of Standards and Technology) traceable standards? |
| Do you anticipate the obsolescence of selected CE-marked products? | {ab74f100-9492-4b5b-bfbb-1a07320b93da}Do you anticipate the obsolescence of selected CE-marked products? |
| Are offsite databases preferred over onsite databases? | Are offsite databases preferred over onsite databases? |
| What are parenteral drug products? | What are parenteral drug products? |
| How are particle count measurements taken? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}How are particle count measurements taken? |
| Where can I find guidance for proper calibration of my air and/or liquid particle counter? {d068caa5-ddce-4673-8182-8bb027e5847b}|{6b81a591-2b23-47f4-8f1e-7df0b29afd77}|{f1039b12-bca0-4185-bdad-4efc9ddd03d3}|{fc2c5b0a-747d-4519-9b40-7705ec608849}|{fdbdb341-efd0-499f-be36-332bf93f72f8}|{da12b452-2119-46ee-951f-1f88f8912e59}|{960b5c2c-b852-4c5f-874a-a26b59652bc7}|{90b48452-7722-4b97-9610-74626f7bd3b1}|{6cc809af-8eb6-405f-a5c3-cec8bb4855f6} | {5a96c3ac-a1e7-41bb-84f0-545bee773a05}|{ae58fb2d-eb96-4b5d-8149-2d5a3743f7c3}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? {d068caa5-ddce-4673-8182-8bb027e5847b}|{0940f4ac-7b9b-48d6-984d-f9e2c42532ae}|{6cc809af-8eb6-405f-a5c3-cec8bb4855f6} | {5a96c3ac-a1e7-41bb-84f0-545bee773a05}Why is counting efficiency checked at each calibration interval? |
| How are ‘particles of interest’ measured in cleanroom and controlled processing environments? {16d8196d-ab69-4272-8e11-a03e1605b1b8}|{e38f1b19-18af-4e5e-ae66-1c34eec14e82}|{70bf5ed9-25ab-4502-93f5-5414aaadc771}|{d068caa5-ddce-4673-8182-8bb027e5847b}|{0940f4ac-7b9b-48d6-984d-f9e2c42532ae} | {ae58fb2d-eb96-4b5d-8149-2d5a3743f7c3}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? | What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring? |
| What are some of the challenges associated with protein-based formulations? | What are some of the challenges associated with protein-based formulations? |
| What is the rational for the subvisible measurement range? | What is the rational for the subvisible measurement range? |
| What is a “risk-based approach” to 21 CFR 11 compliance? | 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? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}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? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is a threshold noise level and how is it determined? |
| What does USP <1787> cover and how is it different from USP <787>? | What does USP <1787> cover and how is it different from USP <787>? |
| What aspects of the cleanroom environmental monitoring workflow must be validated? | What aspects of the cleanroom environmental monitoring workflow must be validated? |
| What are extractables? | What are extractables? |
| What are leachables? | What are leachables? |
| What is coincidence error and how is it determined? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is coincidence error and how is it determined? |
| What is an Analyte Specific Reagent (ASR)? | What is an Analyte Specific Reagent (ASR)? |
| What is cGMP? | What is cGMP? |
| What is a consensus standard? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is a consensus standard? |
| What is ISO 11171? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is ISO 11171? |
| What is SRM 2806? | {b24812ca-1b6e-4acd-8e71-a9d5229a0669}What is SRM 2806? |
| When can we expect an update to Part 11? | When can we expect an update to Part 11? |
| What are the cGMP requirements for buildings and facilities? | What are the cGMP requirements for buildings and facilities? |
| What are the cGMP requirements for documentation? | What are the cGMP requirements for documentation? |
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