Aseptic process is very critical in drug manufacturing , Facility along with the trained persons are very much important and there handling practices play a very crucial role in the sterility and integrity of the products. First we have to assure yourself before giving assurance to others.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
ISO 9001:20015 bilgilendirme ve farkındalık eğitimi.
Kalite Nedir ?
Müşteri Memnuniyeti
ISO 9001 Gelişimi
PUKÖ Döngüsü
Sürekli İyileştirme
ISO ‘nun faydaları
KYS için gerekli dokümanlar
ISO 9001 Standart Maddeleri
Aseptic process is very critical in drug manufacturing , Facility along with the trained persons are very much important and there handling practices play a very crucial role in the sterility and integrity of the products. First we have to assure yourself before giving assurance to others.
useful for pharmaceutical quality assurance students, MBA and all people including industry employee to improve knowledge about the quality risk management process
ISO 9001:20015 bilgilendirme ve farkındalık eğitimi.
Kalite Nedir ?
Müşteri Memnuniyeti
ISO 9001 Gelişimi
PUKÖ Döngüsü
Sürekli İyileştirme
ISO ‘nun faydaları
KYS için gerekli dokümanlar
ISO 9001 Standart Maddeleri
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Classified environments for aseptic manufacturing of sterile drug subtances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product. A well-designed environmental monitoring (EM) program is important to evaluate environmental controls in classified environments.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
FSSC 22000 V4.1, USFDA FSMA, SQF V8.0 standards now require to address the controls over food fraud & food defense through vulnerability & threat assessment. Our expert will train your team on the requirements & assist in documenting the plan for VACCP & TACCP.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Classified environments for aseptic manufacturing of sterile drug subtances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product. A well-designed environmental monitoring (EM) program is important to evaluate environmental controls in classified environments.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
FSSC 22000 V4.1, USFDA FSMA, SQF V8.0 standards now require to address the controls over food fraud & food defense through vulnerability & threat assessment. Our expert will train your team on the requirements & assist in documenting the plan for VACCP & TACCP.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.