Medical Device Courses | Fady Khalla | Activity

Fady Khalla replied to the topic "CROs" -

Wed, 15 May 2019 16:57:27 -0400

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… Read more»

Fady Khalla replied to the topic "Consent and predicted outcome" -

Wed, 15 May 2019 16:57:26 -0400

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… Read more»

Fady Khalla replied to the topic "Simulation Experience" -

Wed, 15 May 2019 16:57:25 -0400

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… Read more»

Fady Khalla replied to the topic "Significant risk vs Non-significant Risk" -

Wed, 15 May 2019 16:56:22 -0400

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… Read more»

Fady Khalla replied to the topic "Non-Conformity" -

Wed, 15 May 2019 16:55:35 -0400

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… Read more»

Fady Khalla replied to the topic "Discussion Topic: Vagueness of GMP's" -

Wed, 15 May 2019 16:54:42 -0400

Hi All, Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to understand what should be done…. Read more»

Fady Khalla replied to the topic "No GMPs" -

Wed, 15 May 2019 16:54:41 -0400

Hi All, This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is looking to buy some parts or equipment from a supplier and I… Read more»

Fady Khalla replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" -

Wed, 15 May 2019 16:54:40 -0400

Hi All, This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are issued to explain the timeframe of implementation and the criteria that must be met… Read more»

Fady Khalla replied to the topic "Go or Kill" -

Wed, 15 May 2019 16:54:00 -0400

This is a great question, and I am currently experiencing that in my current position. Most of the time, projects that are given the GO decision are executed till commercialization. Most of these projects are usually well planned, budgeted and… Read more»

Fady Khalla replied to the topic "product manager role" -

Wed, 15 May 2019 16:53:59 -0400

I agree with all the aforementioned comments that all these roles are crucial for a product manager. The one point that I have to elaborate on is the ability of the product manager to understand the factors that could affect… Read more»

Fady Khalla replied to the topic "Product Failure" -

Wed, 15 May 2019 16:53:57 -0400

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a different model number that looks similar…. Read more»

Fady Khalla replied to the topic "Types of Validation" -

Wed, 15 May 2019 16:52:10 -0400

Hi Viraj, you did bring up a good point. Validation can occur at multiple stages along the manufacturing process. Your prospective validation example is relevant to the kind of validation that should occur while to ensure that the process is… Read more»

Fady Khalla replied to the topic "Discussion Topic: Playing with IQ, OQ, PQ" -

Wed, 15 May 2019 16:51:16 -0400

Hi Andrew, I like the examples you provided for IQ, OQ, PQ for prefilled syringes, but I think that the IQ for a Syringe filling line may be a little different. For example the Installation qualification may include the following:… Read more»

Fady Khalla replied to the topic "Discussion Topic: Differences between ISO and FDA" -

Wed, 15 May 2019 16:51:16 -0400

Hi All, I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if the process cannot be fully verified by inspections or test. Some Manufacturers use In-line inspection methods,… Read more»

Fady Khalla replied to the topic "Standard Operating Procedures (SOP's)" -

Wed, 15 May 2019 16:50:19 -0400

HI Luisa, you raised a very good question that concerns many companies. A quality system is the backbone of any organization. it defines the structure of the organization as well as define the roles and responsibilities of each member in… Read more»

Fady Khalla replied to the topic "SOP: how much detail before too much detail?" -

Wed, 15 May 2019 16:50:19 -0400

Hi Chris, I have ran into your situation multiple times. SOPs are supposed to be written in very specific details. It is also supposed to be written in a step-by-step format in order to be easily followed. Each step in… Read more»

Fady Khalla replied to the topic "Discussion Topic: ECO's" -

Wed, 15 May 2019 16:49:45 -0400

Hi All, In my previous job I had to issue ECOs for many purposes including: – SOP Changes/updates – New SOP Release – Process Changes – Product Specification Changes – Documentation Updates The reason why we used ECOs in everything… Read more»

Fady Khalla replied to the topic "DHF vs. DHR" -

Wed, 15 May 2019 16:49:44 -0400

I have gone through the same process a while back when I first started working with design controls. It was always confusing what is the difference between a DHR and a DHF. Reading definitions may not be very helpful until… Read more»

Fady Khalla replied to the topic "Discussion Topic: Post-market surveillance" -

Wed, 15 May 2019 16:49:43 -0400

Hi All, I believe all of you have identified so many ways that post market surveillance can be conducted. The main pitfall that I have seen manufacturers fall in most of the time is the understanding of the term post-market…. Read more»

Fady Khalla replied to the topic "Discussion Topic: Is the DHF a living document?" -

Wed, 15 May 2019 16:48:42 -0400

I am one of the people that believe that DHF is a living document. Any changes to the Device Must be included in the DHF. I also believe that any changes have to go through a design transfer especially changes… Read more»

Fady Khalla replied to the topic "DHF vs. Tech File/Design Dossier" -

Wed, 15 May 2019 16:48:41 -0400

The DHF and Technical file are different documents that have the same content. The Technical File is a snapshot in time of the design without giving much consideration to the design history or the mistakes that were corrected along the… Read more»

Fady Khalla replied to the topic "Guidance Documents" -

Wed, 15 May 2019 16:47:55 -0400

Hi Andrew, I have always used Guidance documents to get better clarification on what the regulation is actually looking for. More specifically, I have used multiple MEDDEV guidance documents to make sure that I am following the right path when… Read more»

Fady Khalla replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:47:54 -0400

Hi all, From my limited experience, it is indeed a lot easier to obtain EU approval prior to US approval. The main reason in my opinion is that in EU the manufacturer is not dealing directly with the regulatory agency…. Read more»

Fady Khalla replied to the topic "Discussion Topic: Your Field or Profession" -

Wed, 15 May 2019 16:45:15 -0400

Hi All, I have to agree with most of you regarding 3D printed medical devices becoming a popular trend. I currently work in a pharmaceutical company handling design controls and Risk management activities for their combination products. I see that… Read more»

Fady Khalla replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 16:44:13 -0400

From a legal standpoint, a written agreement is far more better than an oral one. As others have mentioned, a written agreement can be easily defended in court and can solve disputes quickly. with an Oral agreement, you get into… Read more»

Fady Khalla replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 16:44:12 -0400

Hello Roberto, The gift restrictions are established by the Sunshine Act that came into effect in 2010. I had to personally abide by the restrictions of the Sunshine Act before. We were conducting a clinical study at one of the… Read more»

Fady Khalla replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 16:43:23 -0400

As I have mentioned in a different post. I work in a hybrid organization that utilizes Functional and Matrix organization. This hybrid type uses project managers within departments. There is no specific team responsible for project management. Coming from a… Read more»

Fady Khalla replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 16:43:22 -0400

I believe that all the responses above have mentioned what are the best practices to form a good project team. from my personal experience. Most of the time, you do not get the chance to pick your team members or… Read more»

Fady Khalla replied to the topic "Risk Identification" -

Wed, 15 May 2019 16:39:52 -0400

I believe that all the responses here are very valuable and they offer very good methodologies on how risks are identified. From my experience, Risk identification starts from the intended use, intended users and use environment. Once all these have… Read more»

Fady Khalla replied to the topic "Minutes for meetings" -

Wed, 15 May 2019 16:38:29 -0400

Good discussion so far everyone. As everyone have mentioned, Meeting minutes is considered to be a very important tool to track project progress and keep everyone on track. From my experience, if you conduct a lot of meetings (especially virtual… Read more»

Fady Khalla replied to the topic "Design input sources" -

Wed, 15 May 2019 16:37:04 -0400

Design inputs do not only include physical and performance characteristics of the device. Design inputs should also include functional requirements, safety requirements, applicable regulatory requirements and -where applicable- information from previous similar designs. I have seen many companies struggle with… Read more»

Fady Khalla replied to the topic "Design Verification & Validation" -

Wed, 15 May 2019 16:36:57 -0400

This is a very common question in the medical device industry. The best way to look at it is to understand the definition of both Verification and Validation. From 21 CFR 820: – Design validation means establishing by objective evidence… Read more»

Fady Khalla posted a new topic "Unexpected Clinical Study Results" -

Wed, 15 May 2019 16:34:15 -0400

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,… Read more»

Fady Khalla posted a new topic "Clinical Study Location/cost vs. results" -

Wed, 15 May 2019 16:34:14 -0400

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… Read more»

Fady Khalla posted a new topic "Management Responsibility" -

Wed, 15 May 2019 16:34:09 -0400

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… Read more»

Fady Khalla posted a new topic "Internal Audits for small organizations" -

Wed, 15 May 2019 16:34:09 -0400

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… Read more»

Fady Khalla posted a new topic "Maintenance & validation" -

Wed, 15 May 2019 16:33:51 -0400

Medical Device manufacturing processes are now heading towards full automation which is a way used by manufacturers to reduce the risk due to human errors. These automated machines and equipment are fairly costly, large and complicated. During process validation, the… Read more»

Fady Khalla posted a new topic "Validation Expiration" -

Wed, 15 May 2019 16:33:51 -0400

Hello Everyone, As I am learning more and more about validation (IQ, OQ, and PQ) I came across a question that may be of interest to many of you. We all know that once any changes occurs to the equipment,… Read more»

Fady Khalla posted a new topic "Process Revalidation" -

Wed, 15 May 2019 16:33:47 -0400

Dr. Simon introduced process validation and IQ/OQ/PQ concepts this week. Based on 21 CFR 820.75, if any changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented…. Read more»

Fady Khalla posted a new topic "Quality Management System Documentation Hierarchy" -

Wed, 15 May 2019 16:33:43 -0400

Hi everyone, As we have learned from this week’s simulation, The company’s quality management system documentation hierarchy was as follows : Quality Manual, Quality System Procedure, Work Instructions (a.k.a. SOP). I have worked in multiple organizations that have defined their… Read more»

Fady Khalla posted a new topic "Regression Verification and Validation" -

Wed, 15 May 2019 16:33:37 -0400

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" -

Wed, 15 May 2019 16:33:32 -0400

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" -

Wed, 15 May 2019 16:33:28 -0400

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)" -

Wed, 15 May 2019 16:33:28 -0400

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" -

Wed, 15 May 2019 16:33:26 -0400

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" -

Wed, 15 May 2019 16:33:22 -0400

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"" -

Wed, 15 May 2019 16:33:16 -0400

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" -

Wed, 15 May 2019 16:33:16 -0400

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" -

Wed, 15 May 2019 16:33:11 -0400

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?" -

Wed, 15 May 2019 16:33:11 -0400

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»