-
Fady Khalla posted a new topic "Regression Verification and Validation" – 6 years, 2 months ago
As we all have learned this week from Dr. Simon, If any of the Verification or Validation test cases have failed during the V&V processes, the specifications have to be either reviewed or changed and these tests have to be… Read more»
-
Fady Khalla posted a new topic "Combination Products in EU" – 6 years, 2 months ago
Hi All, As we all know, the US FDA handles Combination products according to their Primary Mode of Action (PMOA). For example, If the device PMOA is through chemical interaction, its approval process is handled through Center of Drug Evaluation… Read more»
-
Fady Khalla posted a new topic "Multi-Center Clinical Studies" – 6 years, 2 months ago
As we all have learned from Dr. Simon’s lecture this week. There are multiple types of clinical studies, including: 1- prospective 2- retrospective 3- Blinded 4- Randomized 5- placebo controlled 6- Multi-Center There are many advantages of doing a clinical… Read more»
-
Fady Khalla posted a new topic "Primary Mode of Action (PMOA)" – 6 years, 2 months ago
As we all know, The definition of the Combination product is ” a product comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a… Read more»
-
Fady Khalla posted a new topic "Consultants NDAs and CDAs" – 6 years, 2 months ago
Hello Everyone, we all learned this week about NDAs and CDAs. After working with consultants for about 3 years. I realized that some of them do not bind by the NDAs or the CDAs they sign. From my experience, We… Read more»
-
Fady Khalla posted a new topic "Organization Type vs. Effectiveness" – 6 years, 2 months ago
As we all have learned from this Week’s videos, each organization structure has its own pros and cons. Each company is structured in a certain way to allow for full utilization of all available resources. I have worked in different… Read more»
-
Fady Khalla posted a new topic "how far is "As Far As Possible"" – 6 years, 2 months ago
The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area where lots of… Read more»
-
Fady Khalla posted a new topic "Usability Risk Analysis" – 6 years, 2 months ago
As we all know, A major step of risk management is risk assessment and identification. Recently, usability has been a hot topic for risk management. Most Regulatory agencies around the world would ask for the company strategy to mitigate risks… Read more»
-
Fady Khalla posted a new topic "Combination Product Phase I clinical Studies" – 6 years, 2 months ago
Combination products have been controversial topic since the introduction of 21 CFR part 4 in 2013. Combination products can consist of Drug & Device, Biologic & Device, or drug/Biologic. Most Drug and Biologic products requires Clinical trials that are divided… Read more»
-
Fady Khalla posted a new topic "When is validation is not required?" – 6 years, 2 months ago
As we all have learned this week, a validation may not be required if: – There were no changes required to the product after verification. – A clinical trial is not required – Product changes did not affect the user… Read more»
-
Fady Khalla posted a new topic "Design Controls for Legacy Combination Products" – 6 years, 2 months ago
Let me start by defining what a legacy combination product is: Legacy Product: Products no longer under development but not retired from a company’s drug development program and are currently marketed in US. Recently, The whole industry has been going… Read more»
-
Fady Khalla replied to the topic CROs in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
I believe that the only responsibility that the sponsor cannot outsource to any CRO is the overall responsibility of the clinical study. I think that any adverse events, injuries and risks will be the responsibility of the clinical study sponsor not the CRO.
As for the advantages of transferring clinical study to CROs, it mainly occurs because…[Read more]
-
Fady Khalla replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
Hi All,
I believe that all of you have touched upon very valuable points. I would like to emphasize that pre-clinical trials (animal trials) are not a safety indicator for many devices. For example, Inhalation devices are not usually tested on animals due to the different anatomical properties between humans and animals. In the case of death…[Read more]
-
Fady Khalla replied to the topic Simulation Experience in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
As everyone have mentioned, These simulations are a very useful tool to mimic what usually occurs in the industry. Although I sometimes think that they only scratch the surface of what actually occurs and the proposed solutions are not always the right way to solve some of these issues, I still believe that they are very helpful tools to reflect…[Read more]
-
Fady Khalla started the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
All clinical studies for medical devices are conducted with the best intention to benefit humans. Based on this week’s lecture, Dr. Simon mentioned that each subject should be informed with a consent form about any reasonably foreseeable risks or discomforts, but we all know that unfortunate results can occur from time to time. Does anybody have…[Read more]
-
Fady Khalla started the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
Through this week’s lecture, we learned more about clinical studies and their setup. One of the major points of considerations during clinical trial design is the location of where the study will be conducted and cost of the study. Do you think that some organizations may choose to conduct a clinical study in a developing country to save on the…[Read more]
-
Fady Khalla replied to the topic Significant risk vs Non-significant Risk in the forum Clinical Trials for Medical Devices 8 years, 3 months ago
Hi Neb2,
From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is used for normal IV infusion may be considered a non significant risk, while as an infusion pump used for epidural anesthesia is Considered a SR since it might cause significant risk.
Therefore, I…[Read more]
-
Fady Khalla started the topic Management Responsibility in the forum Quality Systems Management 8 years, 3 months ago
Based on this week’s lecture, Management responsibility includes the requirement that management should provide adequate resources to achieve a fully functioning quality management system. With our current economy, Organizations are usually under budget restrictions and management have to deal with constant budget cuts. Employees have to take the…[Read more]
-
Fady Khalla replied to the topic Non-Conformity in the forum Quality Systems Management 8 years, 3 months ago
Non-conforming materials is a very common issue that almost all manufacturers deal with on daily bases. it ranges from regular suppliers to product coming out of the line that does not meet specifications. The most recent non-conformity that have dealt with was when parts from a certain supplier started failing incoming inspection due to the…[Read more]
-
Fady Khalla started the topic Internal Audits for small organizations in the forum Quality Systems Management 8 years, 3 months ago
This week, Dr. Simon highlighted the importance of quality audits and especially internal audits. The FDA expects each organization to conduct at least one internal audit per calendar year. Internal audits are usually conducted in parts by independant employees to the part/process being audited. This can be a huge burden on small organization that…[Read more]
- Load More
