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GCP Clinical Auditing

GCP auditing expertise which can help you to meet the international ethical and scientific standards of Good Clinical Practice

A company that conducts clinical trials on investigational medicinal products (CTIMP) or medical devices that involve the participation of human subjects, must prove that the design, study conduct, performance, monitoring, auditing, analysis and reporting, all meet the international ethical and scientific standards of Good Clinical Practice (GCP). 

Through our GCP auditing capabilities, we can provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. Laboratories that perform analysis of clinical trial samples must also conduct laboratory services to GCP standards.

Intertek provides many global organizations, both product development companies and contract research Organizations (CROs), with GCP auditing expertise. These services help to ensure that adoption of the principles of GCP meet international standards where trials are conducted to test both medical and non-medicinal products such as nutritional foods or cosmetics. Supporting GCP compliant human clinical trials, our GCP compliant laboratories provide a wide range of GCP bioanalysis services. Our Total Quality Assurance expertise enables you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.

Intertek's GCP Quality Assurance services:

  • Document review and audit for example SOPs, Clinical GCP Protocols and Reports
  • Audits of submission for ethical approval for GCP clinical trials
  • Facility Inspections
  • Critical Phase inspections of clinical studies
  • System audits
  • Sub-contractor audits (laboratories, archives, waste contractors)

Intertek's QA services also include:

  • Preparation for ISO 9001 (Quality Management Standard) inspections
  • Inspection to ensure compliance with the Human Tissue Act (HTA) 2004 and preparation for a HTA regulatory inspection

QA audit reports and compliance statements can be provided as appropriate. 

Need help or have a question?

Sours: https://www.intertek.com/pharmaceutical/auditing/gcp-clinical/

30-Hour Clinical Research Auditing Certification Program

 30HR Audit

The online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.

The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

  • Describe and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practices (GCPs)
  • Explain the roles and responsibilities of a Clinical Quality Assurance Auditor
  • Describe the types of audits, including the responsibilities of the auditor in preparation, activities, and follow-up
  • Examine and apply the FDA’s methods for inspections of Clinical Investigators, IRBs, sponsors/CROs
  • Discuss regulatory compliance and quality assurance issues and documentation
  • Module 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
  • Module 2: Auditing as a Profession and Compliance Tool
  • Module 3: The Types of Clinical Research Audits and Preparation
  • Module 4: Quality Systems for Auditing
  • Module 5: Risk-Based Auditing and Developing Risk-Based Auditing Plans
  • Module 6: The Auditing Process: Clinical Investigator
  • Module 7: The Auditing Process: Institutional Review Board/Ethics Committee
  • Module 8: The Auditing Process: Sponsor/CRO
  • Module 9: Gathering and Disseminating Information: Verbal and Written Communication
  • Module 10: Regulatory Classification and Communication: Recent Inspection Findings
  • Clinical Quality and Compliance Professionals
  • New or Aspiring Auditors
  • Clinical Research Associates
  • Project Managers
  • Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Research Coordinators
  • Clinical Principal Investigators
  • IRB Administrators and Members

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

10 weeks for 3 hours each week.

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-20-063-L04-P. Released: 8/20. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

Sours: https://www.barnettinternational.com/Web-Seminars/30-Hour-Clinical-Research-Auditing-Certification-Program/
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Love my job as a GCP Auditor

GCP Auditor (Remote/Europe-based)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

A GCP Auditor will be responsible for planning and conducting GCP audits (vendor, internal process and investigator site) on behalf of ProPharma Group clients.  The GCP Auditor will also act as a Subject Matter Expert (SME) for clinical-related projects and will be responsible for developing and managing the clinical auditing program.  This position is responsible for independently managing clinical-related projects and providing consulting and contract services to clients as needed.  Additionally, the GCP Auditor is responsible for designing, implementing, monitoring and maintaining ProPharma Group’s clinical auditing program, policies and strategies and ensuring company compliance to GCP regulations, internal procedures and policies in cooperation with peers.

This Function includes the following responsibilities:

  • The GCP Auditor will be subject matter lead for clinical consulting and will be leading auditing projects within ProPharma Group. 
  • Execute audits based on experience and a comprehensive understanding of all international regulatory requirements related to clinical trials, including ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP).
  • The GCP Auditor will be a critical team member who contributes to the implementation of a risk-based GCP audit program and provides oversight / management of the GCP consulting program.
  • Promote continual improvement regarding customer satisfaction with emphasis on GCP consulting services.
  • Keep pace with advances and technological changes in clinical support Services within the pharmaceutical / device / biotech industries and promote those that will increase the company’s effectiveness and profits.
  • Provide support to clients and all functional units of ProPharma Group as clinical compliance issues such as deviations and non-conformaties arise.  Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformaties.  
  • Ensures compliance of company operations to quality principles and participates in the development of quality systems through SOP writing and training.
  • The GCP Auditor is responsible for promoting GCP subject expertise through publications and presentations through professional networks.
  • Support the generation of proposals for GCP auditing and clinical-related projects.
  • Utilize expertise of quality systems, data integrity, software compliance and GCP requirements to conduct audits and provide Gap analyses and risk assessments for clients.

Qualified candidates must have:

  • B.S./B.A in scientific discipline as a minimum.  A graduate degree in a scientific discipline is preferred.
  • Minimum 5 years of experience in a GCP environment.
  • Minimum 3 years of experience in an international GCP quality assurance role, including leading GCP audits.
  • Ability to interact in a professional and positive manner with clients and co-workers. 
  • Exceptional communicator with strong persuasion skills and presentation skills.
  • High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. 
  • Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project. 
  • Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team. 
  • Experience creating and working with high performance teams.
  • Ability to organize and manage multiple projects.
  • Quality orientation and high attention to detail, keeping the bigger picture in mind.
  • Ability to think ahead and prepare action plans to achieve results.
  • Excellent analytical skills and the ability to access and resolve difficult business situations.
  • Ability to read, prepare and analyze data for development of reports.
  • Excellent English language skills.
  • Flexible to travel on a global basis.

This is a home-based/remote working position, with the GCP Auditor living within Europe, and willing to travel globally.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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Privacy PolicySours: https://www.smartrecruiters.com/ProPharmaGroup/743999691364694-gcp-auditor

Auditor gcp

Clinical Trial Good Clinical Practice (GCP) Audits – Are you ready?

Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects. Investigators, sponsors, clinical research organizations (CROs), and institutional review boards (IRBs) must have a working knowledge of GCPs for assurance of the best protection of human subjects and the preservation of the quality, reliability, and integrity of the data.

The GCP audit is the interface for this assurance. It is carried out to assess compliance with regulatory requirements for the clinical trial protocol and the clinical quality management plan (CQMP) by the principal investigator and all of the site support personnel. The CQMP is an extension of a sponsor or CRO’s quality programs and standard operation procedures. During the site feasibility and qualification process, the sponsor or CRO personnel will not only be checking professional credentials but also the ability and resources available to carry out the assigned duties of the site, both professionally and administratively. Not being compliant can lead to failures, delays, unrecognized adverse events, and most importantly, loss of protocol and data integrity. This could lead to a challenge of the clinical trial results by regulatory authorities.

GCP audits can have different purposes relative to the clinical trial process. It is not always a site(s) and monitoring audit—a GCP audit can be a full clinical trial audit over systems and operations conducted by monitors and trial management, a full clinical trial audit over the clinical trial sites, or an audit of the CRO carrying out the clinical trial on behalf of the sponsor. A GCP audit can also be conducted for the qualification and selection of a CRO. Audit scope can be for the purpose of auditing data management and electronic data capture (EDC) systems, electronic medical records (EMR) integrity, interactive response technology (IRT) systems such as IVRS and IWRS, regulatory compliance for essential document collection and integrity throughout the study, for institutional review boards/international ethics committees, specialized Phase 1 unit compliance, Phase 1 SOP development and training, or over third party vendors.

Experienced auditors will help identify potential risks and help to ensure that the compliance issues do not jeopardize the study. It is obviously useful that the clinical trial auditor has a good understanding of the clinical trial process and objectives. Of particular interest to a potential site is the site qualification process and compliance expectations before, during, and after the clinical trial. Of further importance to the site is the need to be transparent about the site responsibilities within the CQMP. Once selected, the site wants a clear and thorough study start-up process and an explanation of the potential for an audit by the sponsor or regulatory authority. That means that each member of the site team has obligations to fulfill with regards to the CQMP and GCP compliance.

CQMP requires each site to have a quality management coordinator. The quality management coordinator works closely with the principal investigator and the clinical study coordinator (CSC). The purpose of the CQMP is to identify and document the ongoing processes and activities that are used to monitor and facilitate quality protocol execution, including data collection and entry following study initiation. A good compliance organization can support the development of this CQMP for discussion during the clinical trial kick-off and initial investigator meeting.

The site CSC has the responsibility to see that all study personnel have completed all required institution-specific and protocol-specific trainings and that these trainings are documented appropriately in the training log. The site will maintain a delegation of responsibilities log. The CSC will verify that all training is current and appropriately documented on a quarterly basis.

Finally, the quality management coordinator will assure on a quarterly basis that a report is filed internally as a reference for the CRO clinical research associate and other external clinical trial responsible parties. This report will include assurance of integration of new personnel, consent process completion, source document completion and review, eCRF review to minimize correction of induced data entry errors, assurance of ongoing equipment calibration and maintenance, proper handling of investigative product and logs, and awareness of any protocol or study changes based on shared data with other investigators. The report will document other matters related to important events such as SAEs and AEs and note any corrective actions undertaken by the site independently or at the request of the CRA from the sponsor or CRO.

These site responsibilities are a serious part of the clinical trial process. The conduct of a thorough GCP audit will include the review of the information found in the CSC report. This CSC report is crucial to the GCP audit and contributes to a speedy site audit, but because the CSC requirement is not well understood with most sites and principal investigators, we will address this in a future blog.

A meaningful GCP audit of a clinical trial will focus on the integrity of this process and the compliance of the site with all aspects of the protocol and the actions of each person who handles some aspect of the clinical trial. With the 21st Century Cures Act calling for more patient-centric analysis and real world experience during and after the clinical trial, it behooves clinical trial sites to understand the necessary quality standards compliance and to be organized and prepared for the GCP audit that is sure to come.

Are you and your administrators ready to address these ongoing compliance aspects of the clinical trial process? Be an attractive site to work with. A little diligence to be ready will put you at the top.

 

 

Sours: https://www.propharmagroup.com/blog/clinical-trial-good-clinical-practice-gcp-audits-are-you-ready/
Love my job as a GCP Auditor

By Iain Pulley, director, Closed Loop Quality Ltd

Imposter-Syndrome-iStock-1060980496

How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

But what happens when we go to a new office? How many of us pore over maps to plot the route step-by-step? Or do we cheat and program the address into our global positioning systems (GPS), slavishly following every instruction, hoping it takes us to the right destination?

What happens, though, when we have to go somewhere, but we don’t exactly know where it is? What if we aren’t able to prepare extensively but only have a vague idea of where we are going? How do we ensure we reach the right destination?

Sounds nerve-racking, doesn’t it? Yet, this can often be the case in auditing.

A New Auditing Challenge

A few years ago, I found myself in such a scenario. I was working in a company as a good clinical practice (GCP) auditor, and if given an audit type within that area, I was more or less comfortable with what to do, as the subject areas were familiar and I knew what documentation to expect.

That all changed, however, when my local country quality head approached me one day and asked if I could assist with some mock interviews on the healthcare side of the business, in preparation for an external regulatory body audit. I said, “Sure.”

On the outside I was confident, but inside I had a gnawing doubt: I didn’t know what I was auditing. I had very little exposure to healthcare processes, and only a vague notion of what it was they actually did! So, how was I to go about preparing for a series of mock interviews?

My first instinct was to cram on the applicable healthcare processes, like many of us would in preparation for a typical GCP audit. But I didn’t have the time; l had a full workload of my normal day job to perform, which limited my scope for intensive preparation. And to top that, the list of prospective interviewees kept changing as names were added or removed, so I could not be 100 percent sure what processes I would need to review beforehand.

The Solution: Ask The Right Questions

So, what do to? It seemed I would struggle to perform the interviews, not knowing the subject area and with little time for intensive preparations. Now I had committed, I did not want to risk losing face in front of my peers, or disappoint my quality colleagues who were obviously looking to me to carry the quality assurance flag into the healthcare arena.

However, at this point I had something of a light bulb moment. Not something unique or new (because I am not that smart or lucky!), but more that something clicked in my mind regarding the approach to take. My older auditing colleague in the office had something of a reputation for their auditing style; they would seemingly do the minimal amount of preparation in the run-up (which at the time I found infuriating), yet during the audit would often ask the most pertinent question and uncover a process gap or risk. I had always chalked it up to them having been in the industry long enough to know how everything worked. But then I thought, maybe it isn’t that they know everything. Maybe it’s that they know the right question to ask!

With this in mind, I set about preparing for the interviews. I decided right away that rather than asking detailed questions, I would ask more general questions so interviewees would explain what they did (utilizing the classic five “whys” of auditing), and then ask for evidence of the process in action for verification. Their responses could also be compared against the process afterward to check whether the process was being followed. I also decided to focus on identifying during the mock interviews what quality looked like within the healthcare side of the business, how they ensured consistency, and how management maintained oversight.

I now had a game plan for proceeding with the interviews. But I could not wing it entirely, so I spent some of the remaining time doing some basic preparation, such as requesting the relevant company organograms, and reading the UK Code of Conduct so I had a rudimentary understanding of what was expected. I also prepared some basic cues to assist me in remembering what to ask during each interview.

Applying The Technique

The first day of interviews came, and it would be unfair to say I was not nervous about conducting them. I felt a real sense of impostor syndrome: Would my questions be too light; would my peers see through my questions and quickly realize I knew little regarding the subject area? But it was too late to back out, so there was nothing to do but get on with the interviews. I would be leading the interviews, but a colleague would also observe the interviewee for how they responded and what their body language displayed.

Into the first interview we went, and after some introductory questions to establish the interviewee’s role and background, I launched into identifying what they did, and how they did it. As I got more comfortable with the information, I started to go beyond skimming the surface of the process, asking deeper questions once I had an understanding of the process, and then bringing it back to whether there was evidence to support the process in action.

The first interview went well, with the questions I asked helping to draw from the interviewee a good picture of their processes and how work was performed. Some interesting items were identified where there was a lack of supporting documentation to verify the process described. Buoyed by this, I determined to push on with the questioning style, making some tweaks after each interview based on what we were hearing, and if there were subject areas we wanted to probe further during future interviews.

As we progressed, I realized that although I was not an expert in the subject matter, I knew what questions to ask to unlock information on the process. It also became clear that in the GCP world there is an established paper trail and that in some respects quality management systems are much more advanced than in other business areas. Most importantly, I realized I already unconsciously used this technique to a large degree during previous audits; however, I still approached audit preparation with the view of trying to know the process inside and out beforehand, rather than going with the flow.

Overall, the series of mock interviews went very well, and it got me thinking about how I might use this approach when preparing for future GCP audits. Many important risks and process gaps were identified for our organization during these interviews, all done with minimum prior knowledge and by simply applying a logical approach to understanding what was being covered. How do you balance the temptation to perform detailed and time-consuming preparations, with this new approach of asking general process-related questions?

I used these lessons learned in subsequent system audits to further develop my approach. I found a balance whereby as long as I had a broad understanding of the key processes, I could use that as a basis for asking general questions to obtain more information on aspects of specific processes. It greatly cut down the amount of preparation time required beforehand and allowed me to think more about what I wanted to achieve during the audit rather than focusing on verifying every process detail.

For example, I utilized the above method in an audit for a vendor that provided trial management systems to our company. The audit scope was very broad, and I only had a limited understanding of the company processes being audited. However, by applying what I had learned previously, we came out with some interesting audit results and identified for example issues with how the organization handled quality issues and trained on sponsor-specific processes. I have since used this approach in several system audits where GCP processes were being used in conjunction with other GxP disciplines, such as computer system validation (CSV) and good pharmacovigilance practice (GvP).

Break Free From Silos

In summary, there is always a risk that auditors become too comfortable in their knowledge areas. As a result, we become overly dependent on this knowledge to tell us when something is wrong when auditing, rather than trusting our methodology, experience, and instincts.

To fully develop our auditing style, we should constantly push into new subject areas to the extent that we take our auditing style back to basics and ask ourselves what it is that we do. In many organizations, auditing is siloed into different technical specialties, and it is often perceived as a risk when an auditor has to audit outside of their area of expertise, in case real deficiencies are not identified.

However, what if this actually holds back our development as auditors? What if our strength as auditors is not as technical experts but as experts in process interrogation to identify what needs to be verified? Audits in the GCP arena are becoming increasingly complex, and frequently overlap other GxP disciplines as processes and systems grow more sophisticated. So, if companies are to avoid sending large specialist auditing teams to perform more cumbersome system audits (infuriating their auditees), then one left-field approach could be to create an ethos within auditing departments that encourages and empowers their individual auditors to break free of their specialist bonds and develop an auditing methodology that enables effective interrogation of most processes, even if they may not be a specialist in those areas.

About The Author:

Iain Pulley, director of Closed Loop Quality Ltd, is a freelance GCP auditor with over 12 years of experience auditing both global pharmaceutical organizations and clinical trials. With a B.Sc. (Hons) in product design, he is passionately process-oriented and places strong emphasis on ensuring quality management systems add value to achieve right-first-time results. Pulley has also successfully assisted and coached various organizations in preparation for regulatory authority inspections. His interests in his spare time include skiing, woodwork, and winemaking. You can email him at [email protected] or connect with him on LinkedIn.

Sours: https://www.clinicalleader.com/doc/how-to-conduct-better-gcp-audits-even-when-you-feel-like-an-impostor-0001

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