GCP Mindset: Modern Quality Assurance

hello and welcome at the GCP mindset channel today it's my pleasure to have Petrus go back over here hello good marine yeah and Peter has expert in quality assurance and today the topic is more on quality assurance hello Petra thanks for being here to speak with me about the important topic quality assurance or short QA and we don't want to speak about quality assurance in general but the modern way of QA but let's start with yourself what makes you an expert for quality assurance so thank you very much first of all for the invitation to be here today I would like to introduce myself first so I started my career at the side aesthetic coordinator when I met the clinical trials at the first time then I moved to the CRO and I started career as a clinical research associate and then I had a deeply insight to the clinical studies I performed a different kind of studies for IP manufacturers as well as medical device manufacturers for different therapeutic areas and then I because I was involved in a clinical cooperations as the quality support it was a logical step to move to the quality department and to support the quality management system and then also to oversight it and to perform the audits and because my experience are approximately 20 years in the clinical research area nowadays I am leading the Quality Assurance Department with team of experts of auditors and also the additional like training and development manager and compliance manager 20 years of experience that really a lot of years in QA and you said that you also have been involved in many audits what kind of audits have you done I personally perform several types of audits starting with system audits of indoors or HTML IDC other electronic tools clinical lab and so on including on-site audits for sure and I have been also involved in auditing the sites prior to the inspections of regulatory authorities and I'm also providing the training from the lessons learns from the audits and the inspections themselves I think the audits prior to an inspection they are called mock inspections correct yes yeah and in which countries have you done or it's already I have performed the audits mostly in all European countries as well as in 90 us in Japan and also the Australia so I assume you experience a lot during the last 20 years but what are the main changes in QA during that time from my point of view there were three biggest changes especially in using new modern technologies and applications and systems in auditing as well as to perform the audits remotely and to use data analytics in auditing when I speak to people of our business it doesn't matter to sponsors or CEO all people and I hear very often that they are mixing up terms QA it's the same like um um it's the same like quality control and all the thing is also the same and it's yeah it's for them it's all the same but there are differences and could you plane once again for all our followers what are the differences of all these terms yes sure despite definitions are in current version of ICS GCP they are often misinterpreted or misunderstood so quality management system forms the heart of the company and provides the quality standard rules to provide the services in standard quality and the quality management system is represented by Quality Assurance and quality control Quality Assurance is independent on conduct of clinical studies or clinical projects and is insured by this independent of staff honor that project and is ensuring that there are quality rules and standards in place which are not only connected that they apply according to the regulatory rules and regulatory requirements but also to the company rules the quality control activities are our daily based activities which are performed by the teams which are directly involved in clinic projects and they are performing the clinical projects and it's ensured the disc activities ensure our processes or our projects are performed according to rules and requirements and yeah the quality control activities are performed by all staff involved in the projects okay so the QA activities are much bigger than just auditing auditing is just a part of QA activities but you said already you're also responsible for training development which is also part of QA activities and I assume that if you put more efforts and such activities you need less quality control correct correct and also the auditing is because it's independent control of our activities it's providing lessons learned and how to prevent the mistakes in the future so if you have a such effective quality management system in place then we are on a good way to prevent the mistakes in the future and to learn and to take lessons learn from them you briefly mentioned already the three biggest changes in clinical research but what are the most challenges for you in QA due to these changes from my point of view the auditors have to adopt to these biggest changes as we always spoken about and it means that the auditors need to be trained in to using the new technology and new systems and new tools and how to effectively use them during the auditing and it doesn't mean that they only need to be trained but they need to understand what are the biggest advantages of these systems and also they need to be willing to use these systems during the audits yes I can imagine for example that the electronic and form consonant process that's one of the big changes during the last couple of years and when I think about the last 20 years it was always the most important step in clinical research at sea and from Condon is done correctly and the data integrity is given but when I really look on the electronic signatures on such tools like smartphones honestly these signatures are looking completely different to normal signatures and I think that can also be challenging for an auditor who just learned during the last 20 years it needs to look like this now they need to accept it it looks completely different that that this is still acceptable correct yes correct and it's the way of also thinking about these changes and how to implement them and follow them so the e consent is not yet fully ready to be implemented in all European countries however already we need to think about such challenges which will bring in a future and that will be a challenge because there will be a new techniques and new metrics to be implemented and also developed in terms of e concerns and econ's and signatures so even order trans need to be open minded yes sure but what does it mean such a o- for your daily work as a QA person so I have to switch from traditional way of thinking to the modern one the traditional way of thinking in what I think was that everything was black and white and properly FEA system interpretation as well as a spirit of new technologies to be used because they were not very well known or developed and the new way of thinking is open-minded if there will be new technologies coming they need to be observed in terms of if they are complying with regulatory requirements however not to be afraid to be used them and to use lessons learned from the audit to further development yeah I can imagine that's very interesting because there will come more and more and the frequency of changes is increasing so if you have then not willing as to learn as an auditor you were also killed innovations yes exactly and therefore the auditor only don't need to be afraid of this changes and should be also willing to follow these new trends and also to be capable enough to learn how to use these new systems and technologies to perform the effective audits does this mean that also the way of doing an audit changed yes especially in the system audits the way how to perform the audit changed because in the past we observed that the audits were performed in terms of more reading the processes but nowadays we are performing the audits in way to ask the questions rather than reading the processes because it's in connection to check also the compliance with the processes to understand the processes especially if also new technologies are used in clinical projects we also need to more listen to our oddity and to understand what's in the processes in themselves according to my knowledge auditing comes even from listening and and when I remember some auditors I met already I would not tell them anything because I just like them whereas other people I like very much I'm willing to tell them also something does that also have an effect on the skills of an auditor especially soft skills definitely because the auditor according to my knowledge and my experience if the auditor has excellent skills in communication and also some empathy in terms to listen to what's provided by the oddity then also the oddity will be more willing to disclose the information and disclose how the processes are Ahly working so therefore I think the communication such part of soft skills and also such kind of ability to understand to the profile of the oddity is the key okay that that means that we need the more nice people for audits instead of the old-fashioned policeman like 20 years ago yes pti you told us already that you have done a lot of audits involving on site or the system or its project audits inspections what are the differences for you from the QA point of view yes so first of all there is always the main goal the main goal is to verify that the system is working properly setup properly and is followed properly and just to verify it the differences are between the different type of audits of course the system audits are focused on the system setup then the on-site audits are focused on the site performance and the mock audits are more focused for the preparation and sharing also the lessons learned from the audits or regulatory author inspections which the oddity despite it is on site or at the company so from my experience in fact there are no biggest differences despite this describe however the biggest difference I see if the size of the audit is performed on-site or remotely I can see a in both types of audits in case if it is a remote or it of course the there is not the interaction with the oddity the personal one which means that also some systems or some processes could be misunderstood therefore what I am always implementing in remote audits is also a remote session with the oddity to verify that also I have understood today processes correctly ok but I can imagine that there's also different between the type of oddity I mean when you go to the sides where the investigators hours of study know sirs for them it's more or less that's not the main profession to be study site and the main profession is to have patience so they I think they have also a different way of working you you even don't have a system which you can ordered you just have protocol and the regulations is that also different for an auditor in fact not really because of course they are not following let's say SOPs as we are assisting during the system audits however they are following another type or set of documents like as you set a protocol or any other working instructions how to perform the project at site which of course means that we need to go in detail what needs to be followed during these audits and then it's verified but the main goal is still the same just to verify if we are compliant either if according to your processes themselves or according to such a project specific documentation and what's your job doing pre-inspection audit the per inspection audits includes not only the verification if the auditor is compliant according to the processes or the documentation itself but the main part also during the inspection auditing is to brief the oddity and to prepare the auditive upcoming inspection so it doesn't mean that the side or the oddity needs to clean up everything but just to be prepared what's coming and what could be the potential consequences of the regulatory inspection findings so the main part of that kind of audit and from my experiences I have to say that also the oddity pay more attention to this such kind of mock per inspection audits and also the communication way such kind of part of soft skills is very important part just to get the trust of the oddity and to brief them and prepare them for the upcoming inspection okay that means that you're not only independent controller but also a kind of teacher yeah teacher or trainer yeah and also to sharing the lessons learned we got from our experiences okay let's speak about the outcomes of audits usually you are coming back with findings meaning the deviation between the reference documents and what you really found did something change with all these changes and clinical research also in terms of findings so it may be surprising the observations doesn't really change too much because the type of observations are most of the same in terms of the preservation of the protocol informed consent process or EDC and data collection which has the reason because the ICS GCP didn't change dramatically so the patient rights patient safety data integrity and data quality are still the same standards which needs to be followed and are of course observed and verified during the audits however the all the observations change in the way of a systematic review on the real daily basis and how they are followed in terms that in the past the auditor was not able to recognize if for example data collected in patient questionnaire or collected in a paper CRF we're in real-time and nowadays we are able to follow if we are collecting data in time and the quality of the data collected in time due to an audit trail electronic or yes exactly I know actually both parts as you know and I've worked as auditor but of course I was very often also the or the key and sometimes I'm wondering how it works when all the different systems and the big QM system are audited by one person yeah and then means the person should be expert and pharmacovigilance then also and product vigilance for medical devices then for EDC then for validation when for normal on-site audits and so on different indications different countries that means these persons need to be expert in everything and clinical research which is I think unrealistic that persons know everything and then I'm wondering also about the variation of gradings one auditor ordered the same system says everything is fine then the next auditors coming everything is bad and a lot of critical findings then the next was all changes it's fine again so and when I fees us sometimes I'm wondering how useful our audits really when the variation is so huge do you think about it yeah the variation we could observe is also based on the auditors personality as well as the auditors background as you said nobody could be nowadays an expert for every time of kind of audits for five jiwan's for clinical lab for icy HDCP requirements so therefore it's great if we could have a different kind of auditors with different kind of expertise in this separator RS for the systems for the vigilance and so on otherwise the auditor and the outcomes provided after the audit will be influenced only by the level of knowledge of that part which is audited so just an example if the auditor will be focused on four ICS DCP requirements but will not really understand to the systems to be audited then the real outcomes of that audit will not reflect the situation in the systems because he or she didn't really understand to it so therefore we always recommend if there is a such kind of huge system audit to be performed in the company to involve more experience in it yeah and the funny thing is actually the lacking experience or knowledge and certain system could mean both sometimes they just say everything is ok because I did not understand the system and the next time they can say everything is critical because I didn't understand the process so it's also based on on ego exactly that's of course dangerous when you want to do an independent audit that you have your problems yeah doesn't the personality type of the auditor okay when we have such problems from time to time what can be the solution to get more objectivity and to such audit gradings or audit finding ratings that sends that way yes the objectivity of findings is a key factor how to keep it as an independent verification of the processes or the projects themselves during the audit and one of the potential solution could be that there will be a group which is involved in all the observations grading which means that the auditor will provided descriptions of observations not that you the audit and and other people or another group of people will evaluate it and grade it independently to avoid that the oddity sort of the auditor is influenced by the oddity and by personal feelings God during the audit and this is the similar approach which also has FDA in terms of how to grade the FDA observations not during the inspections okay that of course makes completely sense but it would also mean that freelance auditor has no chance anymore a few would say that's the state of the art yes that's right because the freelance auditor is working independently as a one-man show and therefore such kind of evaluation and independent view on the observations noted during the audit are not possible I mean even in quality assurance which is not I think the the fast-changing part of clinical research we have sometimes trends a couple of years ago we spoke about quality by design now Corti risk management is very modern and even required according to the new IC h e6 guideline i would say sometimes it just makes sense to really use the brain to evaluate quality but what do you think about what use management as factor for improving quality doesn't really make sense what's your thinking about it so quality risk-based approach in our QA part should be implemented in the way and to follow that are not everything to be checked and to understand what are the priorities and what needs to be checked in terms of processes or documents so don't waste the time to check particular details or particular documents but just to focus was important and was important for this study outcomes I have observed also during the audits that also not only oddities but also CRA s were lost in many details because a lot of documents and lot of data are collected and they lost the logical oversight what's going on so therefore it's necessary to implement such a way of thinking the logical way of thinking in the quality risk approach okay as you know I'm a big fan of court use management now an expert question for you when you ordered a project independently and you have the project team considers one part of the study as non-critical so without risk and the other part is risky what do you ordered the risky part they consider risky or the not risky part first I will focus on the risky part but of course I will also evaluate on my own depending of what what the study needs to evaluate and which data needs to be collected to support the primary goal of the study and how the risk evaluation was done so you will order they have done the risk analysis useful and yeah and comprehensive and logical yeah terms of what's the goal of the primary goal of the project okay that makes sense Thanks if the sponsor would come to you and ask you how can I make the QA system more effectively we are putting so many efforts money a time and QA but it's not really useful to improve quality and they come to you and want to do it in a more modern way what would you recommend to them so I would recommend to the sponsor to implement regular quality risk analysis including how to perform effectively root cause analysis and to have effective process for corrective and preventive actions including the follow-up both need to be supported by the training and to have at well-trained staff on board one of the key factor to succeed in this recommendation is the way of communication the communication especially with different nations different languages is the key factor I like this so again like in many other topics communication is the key and we should not concentrate on the blaming game but more on corrective and preventive actions to resolve the problems instead of saying good that we as QA people found mistakes correct yeah that's very good but that also means different profile nowadays when you recruit QA people or especially all the tasks and the personality needs to be different and you need to train them differently you also need to train for much more soft skills instead of just regulations and reference documents what would you suggest for a better more effective training activities in terms of to have a good auditor or board it's coming from different factors to be assessed for such person so first of all also working experience not only in Kalinka research but at all including the personality you have mentioned and the communication skills and then the expertise in the area the auditor will be involved in and first of all the auditor should not consider himself or herself as a god and should understand that we are all humans which means that we are doing mistakes and therefore the auditor should not focus just to simplify the mistakes of oddities or persons involved in the projects but just to understand and then to provide an effective help how to prevent such mistakes in the future so in young girls not so much experienced auditors we could see that they are not really understanding the approach what the audit providing so preventing the mistakes in the future and that they are should not be focused just find the mistakes but to also help to the oddity how to prevent them in the future yeah it means much more consultancy culture instead of control exactly that's my impression yeah thank you very much Peter it was very interesting thank you for being here I also hope that you liked the video about quality assurance that you learned something please leave your comments send us your questions and see you the next time bye bye [Music]

Channel: GCP-Mindset - All About Clinical Research

Views: 704

Rating: 5 out of 5

Keywords: CRO, clinical trials, trials, interview, budget, clinical research organisation, cra, clinical research associate, klinischer Monitor, monitoring, research, pharma, pharmaceuticals, Pharmazeutika, klinische Forschung, pharma industry, Pharmaindustrie, klinische Forschungsorganisation, ethics committee, Ethikkommission, benannte stellen, nominated bodies, notified bodies, gcp-service, Andreas Grund, Forschung, QA, QC, QM, Quality Assurance, quality management, quality control

Id: hoz4eMhiuZo

Length: 28min 42sec (1722 seconds)

Published: Tue Dec 03 2019