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									Process Validation and Process Risk - Medical Device Courses Forum				            </title>
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            <description>Medical Device Courses Discussion Board</description>
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							                    <item>
                        <title>Validation Steps</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/validation-steps/</link>
                        <pubDate>Sun, 04 Mar 2018 17:03:43 +0000</pubDate>
                        <description><![CDATA[In lecture we learned the steps of Validation; I. Determine what to validate (IQ,OQ, PQ), II. Write a validation protocol III. Run the protocol, collect the data IV. Analyze the data V. Make...]]></description>
                        <content:encoded><![CDATA[In lecture we learned the steps of Validation; I. Determine what to validate (IQ,OQ, PQ), II. Write a validation protocol III. Run the protocol, collect the data IV. Analyze the data V. Make improvements/changes based on data V. Prepare a report VI. Keep Documentation as a record.  I'm curious if anyone in Industry has been apart of a Process Validation and if they included any other steps at their company and on average how long it took them to complete this process (From determining what to validate to making any changes based on data/keeping the report as a record)?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>alexandrabuga</dc:creator>
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				                    <item>
                        <title>Process Validation vs. Verification</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/process-validation-vs-verification/</link>
                        <pubDate>Sat, 03 Mar 2018 11:41:34 +0000</pubDate>
                        <description><![CDATA[In the lecture for this topic Dr. Simon explained the difference between process validation and process verification. Process validation is definitely the preferred method, as it ensures the...]]></description>
                        <content:encoded><![CDATA[In the lecture for this topic Dr. Simon explained the difference between process validation and process verification. Process validation is definitely the preferred method, as it ensures the process is highly controlled and ultimately results in a more efficient manufacturing process in the long run. I can think of 2 reasons why companies would choose not to validate a manufacturing process. First of all, it is a large up front cost and time investment to validate a process if you do prospective validation, and for a small start up company, this may not fit their business model. The other reason is that larger companies may have very strict procedures for performing process validation, and sometimes they set the bar too high, making it very difficult to pass the process validation. Since they are unable to pass process validation, they resort to verification, such as 100% inspection. This is something that I have seen happen in my company. 

I would like to hear everyone else's perspective on this, and if you have any experience with these scenarios please share.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>srg36</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/process-validation-vs-verification/</guid>
                    </item>
				                    <item>
                        <title>Gauge R&amp;R Challenges</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/gauge-rr-challenges/</link>
                        <pubDate>Sat, 03 Mar 2018 11:30:07 +0000</pubDate>
                        <description><![CDATA[I&#039;m interested to know if anyone with experience in industry has experience with performing validations on measurement systems, such as Gauge R&amp;Rs (Gauge Repeatability and Reproducibilit...]]></description>
                        <content:encoded><![CDATA[I'm interested to know if anyone with experience in industry has experience with performing validations on measurement systems, such as Gauge R&amp;Rs (Gauge Repeatability and Reproducibility). Similar to how the process used to produce the part needs to be validated, the inspection means used to inspect the part to determine whether it is good or bad also needs to be validated. A Gauge R&amp;R study gives a measure of the uncertainty of the measurement system, accounting for variations within the system itself as well as external factors causing variation such as different inspectors measuring the same part.

Right now one of the projects my company is working on is struggling to pass a Gauge R&amp;R. It is a very small part with very small tolerances, and although our supplier believes it can produce the part to our specs, they are unable to pass the gauge R&amp;R, which means we have no way of knowing whether the parts are in spec or not since we cannot validate the inspection means. Has anybody run into a situation like this before, or does anyone have experience with Gauge R&amp;R studies?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>srg36</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/gauge-rr-challenges/</guid>
                    </item>
				                    <item>
                        <title>CAPAs: Proactive vs Reactive</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/capas-proactive-vs-reactive/</link>
                        <pubDate>Sun, 25 Feb 2018 13:50:56 +0000</pubDate>
                        <description><![CDATA[We learned this week that Risk Analysis for a process is conducted when the process is first designed, changes are made to process, and when a Corrective and Preventative Action (CAPA) is fi...]]></description>
                        <content:encoded><![CDATA[We learned this week that Risk Analysis for a process is conducted when the process is first designed, changes are made to process, and when a Corrective and Preventative Action (CAPA) is filed on the process. Corrective actions are put in place in response to customer complaints, non-conformities with the product, or issues in processes found during an internal audit.  
To comply with the FDA code FDA 21 CFR 820.100 medical device companies need to establish a CAPA process within their QMS.  In 2017 there were 1,030 483s issued for medical devices. I think its better to have a proactive system in place vs being reactive to CAPAs as a result of issues that have already occurred.  For medical devices, do you think it’s better from a business standpoint to be proactive or reactive?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>alexandrabuga</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/capas-proactive-vs-reactive/</guid>
                    </item>
				                    <item>
                        <title>Technical Writing Skills</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/technical-writing-skills/</link>
                        <pubDate>Sun, 05 Mar 2017 19:05:34 +0000</pubDate>
                        <description><![CDATA[One of the skills that is mostly taken for granted is technical writing. As engineers, we are not only solving problems but working with new products, nevertheless, documentation of your wor...]]></description>
                        <content:encoded><![CDATA[One of the skills that is mostly taken for granted is technical writing. As engineers, we are not only solving problems but working with new products, nevertheless, documentation of your work is also critical. It really does not matter if you are creating a new work instruction or a DCR or a SOP, the way in which these documents are written must be concise, clear and understandable and repeatable for anyone that have to pick up on you work.
 
Now my question to you guys is: Have you guys had any experience at work in which you came across documentation that is not understandable or doesn't make sense? Do you feel that in your undergraduate you were not exposed to a good level of technical writing in which made it hard to transition into your first full time position?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>neb2</dc:creator>
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				                    <item>
                        <title>Maintenance &amp; validation</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/maintenance-validation/</link>
                        <pubDate>Sat, 04 Mar 2017 12:36:10 +0000</pubDate>
                        <description><![CDATA[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 equip...]]></description>
                        <content:encoded><![CDATA[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 manufacturer always include a maintenance schedule as well as a calibration schedule to ensure that the equipment is properly maintained throughout its lifecycle. The question here is that assuming that one of the critical equipment on the manufacturing floor have severely failed and required to be fixed. Does this trigger new validation? Do the manufacturer have to repeat IQ, OQ and PQ after the maintenance was performed?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>Fady Khalla</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/maintenance-validation/</guid>
                    </item>
				                    <item>
                        <title>Validation Expiration</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/validation-expiration/</link>
                        <pubDate>Sat, 04 Mar 2017 12:26:11 +0000</pubDate>
                        <description><![CDATA[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...]]></description>
                        <content:encoded><![CDATA[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, a revalidation may be deemed necessary or at least a justification from quality is needed to justify why revalidation is not necessary. The question I came across is what if no changes occurred to the equipment since validation, and the equipment have been operational and maintained per calibration and maintenance schedule. When will the original validation expire? Is there any regulatory requirement to revalidate the equipment after a certain period of time (e.g. 10 years or 20 years)?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>Fady Khalla</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/validation-expiration/</guid>
                    </item>
				                    <item>
                        <title>Comparing Knowledge of FDA, EU, etc before and after this course</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/comparing-knowledge-of-fda-eu-etc-before-and-after-this-course/</link>
                        <pubDate>Fri, 03 Mar 2017 14:15:17 +0000</pubDate>
                        <description><![CDATA[I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced? 

...]]></description>
                        <content:encoded><![CDATA[I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced? 

I personally have benefited a lot from taking Dr. Simon's courses, I was able to understand how a product is thought out from step one. Not only doing these simulations, but having no industry experience I was finally able to understand how the industry works verses Academia. This is one of the reasons I took an extra class this semester to get the most out of my tuition. I am able to answer most of the interview questions with confidence and actually understand and give examples of how industry works and different job functions. 

So my question to you all is, share your experience of how you benefited from this course?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>tn58</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/comparing-knowledge-of-fda-eu-etc-before-and-after-this-course/</guid>
                    </item>
				                    <item>
                        <title>Simulation</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/simulation/</link>
                        <pubDate>Tue, 28 Feb 2017 14:30:08 +0000</pubDate>
                        <description><![CDATA[Looking at this week&#039;s simulation, 

if you were the customer Arugalo Medical how would you modify your timeline if the component you need from a vendor will be delayed for an unknown time p...]]></description>
                        <content:encoded><![CDATA[Looking at this week's simulation, 

if you were the customer Arugalo Medical how would you modify your timeline if the component you need from a vendor will be delayed for an unknown time period. Since it is critical component what action will you take to make sure this never happens again. 

My answer to this question would be to make sure my company has multiple vendors "dual sourcing" for critical components of any device so we do not lose any money on the market. This is important because this makes sure you will always have a product on the market.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>tn58</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/process-validation-and-process-risk/simulation/</guid>
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				                    <item>
                        <title>Holistic Qualification</title>
                        <link>https://medicaldevicecourses.com/forums/process-validation-and-process-risk/holistic-qualification/</link>
                        <pubDate>Sun, 26 Feb 2017 17:37:08 +0000</pubDate>
                        <description><![CDATA[Hi All, 
I was wondering if anyone knew of the concept of a Holistic Qualification/ Holistic Approach for Qualification, I know by definition it is done at the user site and it involves the ...]]></description>
                        <content:encoded><![CDATA[Hi All, 
I was wondering if anyone knew of the concept of a Holistic Qualification/ Holistic Approach for Qualification, I know by definition it is done at the user site and it involves the entire instrument and software system. I was wondering if anyone knew more about the type of qualification approach and when could it be done.

Chris]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/process-validation-and-process-risk/">Process Validation and Process Risk</category>                        <dc:creator>Chris Vasquez</dc:creator>
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