PS-1: Aligning PAM audits & QA in-process inspections; Two for the Price of One (J Heléne Andersson, Toxikon)
Post approval monitoring (PAM) of animal welfare protocols by the Institutional Animal Care and Use Committee (IACUC) is required. Monitoring inspections can be performed in conjunction with GLP in process phase inspections for in vivo portions of a GLP study. The objectives of the two inspectional processes are different; however, there is significant overlap in what is reviewed. Combining these inspections adds value and efficiency to laboratory processes and ensures GLP auditors are aware of animal welfare concerns along with GLP compliance.
PS-2: The intragastric method for administration in laboratory animals at GLP preclinical studies (Maria Zaytseva, The institute of toxicology; Alena Shultz, FSSI The Institute of Toxicology FMBA RF; Dmitry Lisitskiy, The Institute of toxicology; Anastasia Bondarenko, The Institute of Toxicology)
The intragastric method of administration in laboratory animals imitates the oral intake of the drug by humans in clinical practice. It is the most commonly used method in preclinical studies. This type of injection is used in the tests OECD 420,423,407,408, 409, 410 425.The intragastric method is used on different types of laboratory animals such as dogs, cats, rats, mice, guinea pigs, rabbits and hamsters. The exploring solutions, suspensions and emulsions are introduced by using a probe. The probes have different shapes - straight or curved, size and diameter of the tip - metal, rubber, elastic soft. Researchers select the probe the type and weight of the laboratory animal. Rubber or elastic soft intragastric probes are used for large laboratory animals and metal atraumatic probe with olive at the end is more often used for small laboratory animals.Straight-shaped probe is used for mice and hamsters and the mostly curved one is used for the rat. The allowable volume of injection varies depending on the type and weight of the animal. If the method of intragastric injection is not observed the following complications are possible: the probe can be inserted into the dog’s, cat’s and rabbit’s trachea, which will lead to aspiration. Mechanical damage of the oral mucosa, larynx, esophageal / tracheal perforation is possible in rats, mice and hamsters. It is necessary to carry out quality control after intragastric administration. The probe movement through the esophagus should not cause difficulties. The probe must pass easily and unhindered. The lack [cut off on submission]
PS-3: Animal Health Industry Challenges of Submitting eSource Data (Damon Bradley, Bayer Animal Health)
The use of web-based electronic data capture systems (EDCS) for animal health study conduct has led to challenges with submission of raw data to the Center for Veterinary Medicine (CVM) within the Food and Drug Administration. This is due to format limitations of e-Submitter, the electronic submission tool utilized by CVM, and the distinct differences between raw data and electronic records. An Electronic Data Capture Working Group within the Society of Quality Assurance (SQA) Animal Health Specialty Section (AHSS) was established to investigate this issue and strategize resolutions. The first outcome of the working group was the white paper “Animal Health Industry Challenges of Submitting eSource Data”. The objective of the white paper is to outline web-based EDCS proprietary formats, discuss challenges in providing e-source data to FDA CVM in their preferred formats, and propose solutions that may be beneficial to both the Animal Health industry and CVM.
PS-4: Quality control of the test system (Maria Zaytseva, The institute of toxicology; Tatyana Kashina, The Institute of toxicology; Elena Volkova , FSSI The Institute of Toxicology FMBA RF; Yuriy Vikharev, FSSI The Institute of Toxicology FMBA RF)
When performing experimental work on biological test systems it is necessary to keep sanitary rules and carry out a set of sanitation measures to maintain acceptable sanitary conditions of work area and its subjects. In this regard the plan of environmental control inspections should be developed. Environmental control of test system housing area is included in monitoring of laboratory animals health. In particular:
Control/estimation of working area (cleanliness and sanitary condition, removal of medical and biological wastes);
Control/estimation of operation environment (measurement of temperature, dampness, lightness, noisiness, air exchange rate, air gas composition);
Control/estimation of laboratory animals (animals health in terms of clinical and microbiological scores);
Control/estimation of nonproduction materials (safety of food, litter for animals and water).
The conclusion about test system housing area safety is made in accordance with regularly taken data. Safety of test system housing area directly impacts on personnel and laboratory animals health and in turns on final results of the study.
PS-5: Professional Characteristics of a Good Auditor: Internal and External (JoAnn Boyd, Southwest Research Institute)
A professional auditor will conduct behavior in an effective manner, both internally and externally to provide value added of the organization and facility affected. This presentation will discuss the qualities, skills, roles, and qualifications of a professional auditor. Good auditing techniques will obtain critical information and the ability to provide proper reporting in support of the feedback needed. This presentation will also identify poor auditing practices that affect the organizations ability to resolve issues identified as well as causing critical unprofessional feedback. This type of feedback can result in loss of work for the auditor and loss of rerun clients for internal audits.
This author will provide examples of what an unprofessional audit consequence both internally and externally. The presentation will provide feedback on the correct handling of inappropriate actions that might be conducted. The information will also provide how company staff might handle the external auditor to minimize issues and provide a smoother audit.
Examples will be provided of how the auditor disrupts the organization, what issues are auditor negatives and using positives as a comparison, how to prevent the auditor from disruption, and the potential ability of turning a bad audit into a good audit. Examples of unprofessional auditors and the consequences will also be provided.
PS-6: Monitoring Deviations as a Measure of Quality (Jennifer Chown, Nooshin Davani and James Farmer, Charles River Laboratories)
As industry turns to metrics as a measurement of quality, there is an increased focus on tracking and trending deviations as a quality indicator, however if not managed properly, intense scrutiny of deviations can have a conversely negative impact on data integrity and the quality culture of an organization. A strong quality culture embraces the goal of continuous improvement and transparency of documentation practices.
This poster will explore the basic intent behind deviations as written into the regulations and explore the concept that deviations can be an indicator of good documentation practices, as well as, overall study conduct. It will also look at the risks to quality culture if deviation trending is being used as a key performance indicator without proper assessment of root cause. Under appropriate monitoring and controls, deviations can effectively be used to improve quality in procedures, training, scheduling, and study management. The following points will be considered for maximizing the quality potential that can be gained through continuous monitoring of deviations and ensure that compliance of a regulated study is maintained:
Overall numbers of deviations should be correlated with study type, complexity in study design, duration, root cause and assessed accordingly.
Root cause should be the focus of deviation trending and QRM applied to mitigate, improve procedures.
Establishing a baseline level of expected, acceptable deviations is key to maintaining data integrity and a healthy quality culture.
PS-7: Dangers of the Note to File Epidemic (Bethany Davis Kearney, Clinlogix)
The use of a Note to File (NTF) is loaded with multiple connotations when used in clinical research. The use and misuse has been published in journals as well as FDA 483s, yet misuse continues at staggering rates. In this poster we will guide Quality professionals to introduce the “just say no” concept to their team and provide tips for alternate options when conducting trials. The use of a NTF should be the last resort.
PS-8: QA Inspections: Friend or Foe (Felice Randi LaMadeleine, Toxikon Corporation)
The purpose of QAU inspections is to assess compliance and report to management. QAU can be perceived as a Compliance Cop quoting regulations or as an ally to the technical staff, helping them navigate the regulations to assure and understand compliance. This poster will illustrate the pros and cons of each approach. Different approaches may be appropriate based upon the situation. Open communication among the departments can create a positive environment that helps ensure quality and compliance.
PS-9: Multi—Layered Approach to CRO Compliance Management: Sponsor’s Proposition (Charles Mueller)
The Generic Drug and Biosimilars business requires a robust global and nimble drug development process to react to the global opportunities for licensing of product in multiple countries. The quality control system to support such a development effort must be equally responsive. At Mylan we have built a multi-layer Quality Management System (QMS) that covers audit, quality assurance, and operations monitoring that provides a comprehensive QMS bases on risk management principles that engages the entire drug development organization. This system provide not only the compliance oversight required by regulation but also ensure a continuous improvement process support function as our business continues to change and grow. This presentation will display the model that we have developed and show how we have progressed our QMS “Beyond Compliance.”
PS-11: Risk Based Auditing-Increasing your Impact (Carrie Rice, Covance)
This poster will share the perspective and audit strategies leveraged by a senior auditor involved in planning and implementation of a risk-based audit program across multiple departments. It will include:
Regulatory considerations when designing a risk based audit program
A summary of benefits and challenges encountered
Lessons learned during program implementation
Noted impact of risk based auditing
This presentation will be helpful both to the auditor who wants to reflect on and add to their auditing strategies and to the supervisor who plans to design or promote a risk based audit approach.
PS-12: Human Error Investigation for Effective Training Execution in GLP Quality System (Labhu Sanghani, Jai Research Foundation)
Most data integrity problems attributed to human error results from poor data entry and handling. When these errors go unnoticed, they can evolve into much larger compliance issues. Personnel commit mistakes because either they are not aware or are tightly bound within misconception. These problems can be addressed using a systems approach where the conditions under which individuals work are assessed to determine how the system contributes to human error and using the personal approach, where human error is blamed on the individual. In both the approach it is important to investigate and identify the cause for human error to establish proactive preventive and effective corrective actions and to design effective training program.
Appropriately trained and well organized laboratory staff are key to the successful operation of a GLP facility. Systems are required to drive organizational structure, training and ongoing competency assessment to ensure appropriate accountability and communication during study conduct. Personnel working in a GLP facility must receive direct and detailed training for the performance of all duties and tasks that they likely to perform. Competency assessments must be conducted and recorded for all components of the employee’s training and functional responsibilities upon completion of initial training.
This poster will throw light on critical factors contributing to human errors in the GLP quality system and will discuss the development of effective training program to overcome compliance issues.
PS-13: The Auditor-Auditee Relationship and Attributes of Effective QA Auditor (Labhu Sanghani, Jai Research Foundation)
Quality Assurance is the framework that ensures the evaluation of products in compliance with regulatory requirements. This could achieve through the development, implementation and continual improvement of robust Quality System. For QA Professionals to advice in the set-up and improvement of quality systems for GLP and regulatory compliance demands a wider range of skills. This would include a thorough knowledge of the various experimental processes, good knowledge of the regulations and guidelines, excellent communication and influencing skills, problem solving skills and the ability to propose practical and pragmatic solutions.
In order to have the necessary credibility as an auditor, experience and maturity are essential. QA should possess excellent interpersonal skills, pragmatic problem-solving ability and have a sense of humour. The important skill of a good QA Professional's is to put the auditee at ease. The key attributes of effective QA auditors are: Integrity, Relationship-Building, Communications, Teamwork and Continuous Learning
The important objective of QA audit functions is cultivating trust and respect with auditees throughout the organisation. For this it is important to build productive, highly collaborative and mutually beneficial relationships. This would help to reduce resistance during the auditing process; Increase the speed and volume of information that auditee can deliver in response to QA audit requests; and encourage the auditee to understand and embrace internal audit’s consultative role.
This presentation will discuss the responsibilities of auditors and auditees during audit and key attributes of QA auditor for smooth and hassle free internal audits.
PS-14: Developments in Digital for Training and GxP e-learning in the lean business (Keith Williams, Skillpad Inc)
We will cover the use of digital tools to reduce costs, increase profitability improve efficiencies by using e-learning to build knowledge in critical areas of manufacturing, laboratory, clinical, maintenance and regulatory compliance. We will cover the use of these tools in conjunction with SOP's to enable:
Situational awareness–to ensure that problems are dealt with in an orderly and safe manner to protect the safety and efficacy of the product;
Operational readiness – to elevate knowledge, on-board staff effectively and more rapidly ;
Human Error Reduction – focus on critical tasks and performance consistency.
We will show live digital examples of training materials from Manufacturing, Laboratory and Clinicla lessons, as well as operational readiness knowledge and critical tasks examples.
PS-15: Implementing Quality Managment Processes to Assure Data Quality (Alissa Zellner, RTI Health Solutions; Beth Furr, RTI Health Solutions; Treena Jackson, RTI- Health Solutions; Karen Wolf, RTI Health Solutions; Paul Edmondson, RTI Health Solutions; Brooke Ross, RTI Health Solutions; Norlonn Sturdivant, RTI Health Solutions)
Processes to protect data integrity and reliability are paramount to support patient safety and product quality. However, the “controls for data integrity do not necessarily guarantee the quality of the data generated”, as recently recognized by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) in its ‘GxP’ Data Integrity Guidance and Definitions, March 2018. This poster highlights how one company, RTI Health Solutions, has implemented a quality management process to assure data quality in its research output, with a focus on minimizing the risk of scientific or statistical errors and misinterpretation. This quality management process is aligned with the Plan-Do-Check-Act (PDCA) framework and incorporates a control strategy which holds staff accountable for data quality at critical document deliverable stages. This poster provides an overview of the company’s three layers of data quality control that (1) confirm the accuracy of data, information, and analysis; (2) verify the validity of the scientific content and interpretation; and (3) ensure that the appearance and writing meet internal quality standards. Compliance with the data quality management process is monitored through internal process audits, client project audits and customer satisfaction reporting. The poster concludes with high-level metrics to illustrate the impact of implementing these quality management processes to assure data quality.
PS-16: Assessing Globalized Finished Pharmaceuticals Manufactured through FDA Warning Letters (2013-2017) (Panyun Zhu, University of Southern California; Nahae Kim, USC International Center for Regulatory Science; Michael Jamieson, University of Southern California; Eunjoo Pacifici, USC International Center for Regulatory Science; Amelia Spinrad, USC International Center for Regulatory Science)
Background
In this era of globalization, 40% of finished pharmaceuticals (FPs) sold in the U.S. are manufactured abroad. Although the FDA has offices overseas to ensure the quality of FPs, recent events like impurities in Valsartan demonstrate that quality issues originating abroad can impact U.S. public safety.
Objective/Methods
Quality issues of FPs manufactured in China, India and U.S. were analyzed using FDA warning letters from fda.gov using the key term “finished pharmaceuticals” from 2013 to 2017. Relevant warning letters were organized by country and quality issues were classified using a systemic approach.
Results
Warning letters regarding FPs were issued to 19 companies in China, 24 in India, and 41 in the U.S. Most frequent quality issues in China are “Validation and Verification (V&V)”, “Documentation” and “Facilities, Equipment and Aseptic Processes (FEAP)”. Most frequent quality issues in India are “Data Integrity”, “FEAP” and “Corrective and Preventive Actions (CAPA)”. Most frequent quality issues in U.S. are “V&V”, “Quality Management”, “CAPA” and “Packaging and Labeling.” Similar quality deficiencies including “(V&V)” were observed in China and the U.S; India has more “Data Integrity” issues.
Conclusion
Identifying key quality issues can help U.S. companies outsourcing in China and India develop education/trainings so that risks in areas that are commonly deficient can be mitigated in order to ensure the quality of final products.
PS-17: PK and Immunogenicity of Proteins: Balancing technical and quality regulatory expectations for Ligand Binding Assays (Saravanan Chandran, Syngene International Limited; Aparna Kasinath, Syngene International Limited; Satheesh Velath, Syngene International Limited; Kakali Dhar, Syngene International Limted)
Protein therapeutics or Large Molecule drugs (peptides, proteins, monoclonal antibodies and biosimilars) have proven to be very effective at combating a variety of different disease indications. Large molecule bioanlaysis is particularly challenging owing to the inherent nature of protein therapeutics, biological matrix involved and the complexity of the Ligand Binding Assay.
While a drug mode of action (MoA) specific method need to be developed and validated to support safety and efficacy readouts, to analyse patient samples and determine the outcome involves several steps like from sample collection to sample analysis and data reporting. Regulatory expectation is for large molecule laboratories to perform sample analysis after completion of a robust validation based on requirements from regulators. In today’s global trend, many sponsors prefer to perform bioanalytical method validation and sample analysis in a CRO under a quality regulated environment; preferably a GLP certified laboratory.
Balancing scientific, technical and regulatory expectations will become an easy task for any CRO if systems and processes are not only in place but also reviewed periodically, updated and trainings implemented. In this poster we will discuss Syngene’s experience in successfully implementing quality compliance systems and processes that have been helpful in delivering high quality technical data for regulatory submissions.
PS-18: Current Status of pharmaceutical regulation in Japan (Clinical Research, Clinical Study & Clinical Trial) (Toshiro Asahina)
Recent several serious incidents(COI etc.) that have damaged the reliability of Clinical Research resulted in the enactment of the Clinical Research Act last year. Regulatory requirement of clinical trial in Japan is a little bit specific. In recent years, several incidents that have damaged the reliability of Clinical Research in Japan became evident, leading to the restructuring of the management pertaining to ensuring the ethics/reliability and COI. This resulted in the enactment of The Clinical Research Act in 2018. In addition to this, though ICH-GCP was raised to Step 4 in 2016. the notification has not been published yet in Japan. Taking into consideration all of the above, we will now introduce the history and current situation of Japanese regulatory requirements (pertaining to Clinical Research and Clinical Trials).
PS-19: Application of Audit Data and Metrics for Identifying Trends and Potential Risk Areas (Steve Bliss, ADAMAS Consulting)
Quality assurance (QA) audits are conducted routinely around the world across pharmaceutical, biotechnology and clinical research industries, as part of compliance processes to meet the regulatory obligations. Through the audit process, critical and major observations are made across many studies, in several therapeutic areas in dozens of countries. This bank of information can be effectively utilized to enable clinical operations to identify trends and potential risk areas.
While observations from individual audits can provide useful information on the quality of the data at a particular site/location/study, the observations data collated from multiple audits can provide meaningful metrics to identify overall trends and potential risk areas across sites, studies, organizations and regions.
In this poster, we would like to demonstrate how metrics obtained from audit data can be used to:
* visualize data quality at a glance to identify trends, and
* identify and assess potential areas of risks within and across investigator sites, protocols and regions
This information can then be used to develop risk mitigation strategies and effective Corrective and Preventive Actions (CAPA).
PS-20: Applying a Risk Based Clinical Trials Methodology to Real-World Evidence (Isaac Dallas, Flatiron Health)
The Revision 2 addendum to International Council for Harmonisation (ICH) E6 - Guideline For Good Clinical Practice (the Addendum) provides guidance for sponsors to implement systems to manage quality throughout all stages of the clinical trial process and shift quality management to a risk-based approach. This guidance impacts many levels of clinical trial design and implementation which increasingly includes the use of real-world evidence (RWE).
Flatiron Health (FH) is a technology company, founded on the principles of agile software development and iterative design where the main research focus is electronic health record (EHR) derived RWE. Structured and unstructured data is derived from EHRs by FH’s technology enabled abstraction approach and is used across the clinical research spectrum (i.e., publications, informing clinical trial design, supplementing regulatory applications, etc.).
Designing a Quality Management System (QMS) to satisfy the Addendum in an agile software environment presents a novel set of challenges unique to FH’s business. The QMS is focused on intended use, and uses risk as the driver of oversight and control. FH’s quality activities are designed in line with identified and potential risk while FH’s business processes are tailored to enable cross-functional oversight and accountability that is methodologically repeatable and reproducible.
Designing and optimizing a living, risk-based QMS that is rooted in efficiently promoting quality management,ensuring human subject protection, and the integrity of research data presents a unique challenge in the field of quality assurance.
PS-21: The Intersection of GCP and GMP in Drug Accountability - When the subject is both the beginning and the end of the process (Dani Eaton, bluebird bio; Amy Mucci, bluebird bio)
As medicine become more personalized, and patients are both the start and the end of the manufacturing process, the line between GMP and GCP in the drug accountability process becomes blurred. Ambiguity in traceability, ownership and documentation can create challenges for both the study and the quality teams. Further, preparing for inspections of any scope requires consideration of both the clinical and CMC aspects in parallel and in unison. This presentation will discuss some of these considerations and share experiences in navigating an increasingly complex regulatory environment.
PS-22: Obtaining CAP/CLIA Accreditation in a Canadian Clinical CRO- Challenges and Successes (Tanja McAulay, Caprion Biosciences; Turcotte Annie, Caprion)
It is clearly stated in the CLIA/CAP guidelines that any testing used for a treatment decision for US samples must be performed in a laboratory that is certified under CLIA (Clinical Laboratory Improvement Act). The tests performed by these accredited laboratories are for diagnostic purposes to support physicians in patient treatment. It is however a challenge for Contract Research Organizations to obtain such accreditation since the testing performed is primarily to support the development of drug products within the scope of clinical trials (Phase I, II, III). Based on the intended purpose of these tests they may require to be performed in a CAP/CLIA certified laboratory for patient stratification, treatment selection and dosing regimen. Therefore, the evaluation of testing parameters must be within the clinical protocol objectives and aligned with the intended use of the data.
This poster will expand on how Caprion, (Montreal site) has achieved the CAP/CLIA accreditation within the scope of clinical trials in the drug development programs and the processes required to ensure a successful CAP/CLIA audit and accreditation maintenance. For a Canadian laboratory, there are also additional elements to be considered; laboratory director responsibilities, local laws, multisite study which may involve other countries (ie Europe). Effective communication, effective procedural review with change control, method validation, study conduct, proficiency testing, laboratory director oversight, and other requirements, will ensure that the clinical objectives of the clinical protocol will meet all of the applicable regulatory requirements including the CAP/CLIA.
PS-23: Quality Improvement Study Start Up Consultations Improve Protocol Compliance (Kathleen Wessman, University of Rochester; Jennifer Dolan, University of Rochester; Kelley O'Donoghue, University of Rochester; Kelly Unsworth, University of Rochester)
The University of Rochester’s Office for Human Subject Protection Quality Improvement team (QI) conducts reviews of active research studies to evaluate human subject safety and protocol compliance; reviews are selected using a risk-based approach. In July of 2015, the QI team implemented a Study Start-Up (SSU) consultation service offering on-site evaluation of study documentation after Institutional Review Board approval is obtained but before subject enrollment. A SSU consultation provides detailed study-specific education to Investigators and research team members and evaluates research documentation to ensure compliance with regulations, institutional policies and the IRB-approved protocol.
This qualitative project was designed to evaluate the SSU consultation program in improving regulatory compliance. We compared the number and severity of the review findings for studies that had a SSU consultation prior to enrolling subjects compared to studies that did not have a SSU. The results demonstrate fewer findings (25% fewer) for those studies that had a SSU consultation compared to those that did not. The results related to high-risk areas, such as consenting, data and safety monitoring, adverse event assessment, protocol compliance, and regulatory adherence, also indicate that studies with the SSU have overall significant improvement.
PS-24: Protocol Deviation or Violation: To Be or Not To Be (Dawn Wydner, FDAQRC)
Neither the regulations governing studies with investigational pharmaceuticals (21 CFR part 312) nor those for investigational devices (21 CFR part 812) define "protocol deviation" or "protocol violation." Regulations speak instead about the requirement for complying with the investigational plan, which includes the protocol, and the responsibility of the sponsor to ensure the compliance of clinical investigators. The poster will define both terms, provide examples, and depict 'things to think about.'
PS-25: Auditing Chromatography from a QA’s Perspective in a EPA Regulated Environment (Charles Miles, knoell USA, LLC; Laura Ricci Daye, knoell USA, LLC; Elizabeth Borkowski, knoell USA, LLC; Brooks Mirabella, knoell USA, LLC)
An auditor performing a study-based inspection/audit requires the auditor to ensure that Good Laboratory Practice (GLP), protocol, analytical method, and standard operating procedures (SOP) are followed. The poster presented shows Quality Assurance (QA) Auditor’s steps to follow when inspecting/auditing chromatography. Using the flowchart presented can help auditors save time and become more efficient when auditing chromatography. QA Auditors may audit raw data generated from various instruments or perform in-phase inspections for critical phases and it is the responsibility of the auditor to know what to look for when performing these inspections/audits. Auditors should to read the protocol, analytical method, and SOPs before beginning the inspection/audit to become familiar with the study conduct. Steps to follow when performing an in-phase inspection include checking logbooks are up-to-date for equipment/instrument maintenance, the equipment is suitable and appropriate for the task performed, equipment/instrument calibration has been performed, the analyst is qualified to use the instrument, the appropriate SOP is in the logbook, and instrument equipment numbers/serial numbers match what is in the logbook. When reviewing/auditing chromatography data sheets, QA auditors should check to ensure the instrument conditions reflect what is in the analytical method; printouts contain project number, study number, sample number, treatment level, ID of instrument, date of analysis, instrument operator, and any other information necessary to identify the analytical data. QA auditors should also check linearity plot to confirm y-axis, slope, and correlation coefficient used correctly in the linear equation; and sample injection summary reports to confirm calculated concetrations are accurately reported.
PS-26: Identification and study of chemical products in compliance with GLP OECD (Maria Zaytseva, The institute of toxicology; Alisa Belskaya, The Institute of toxicology; Margarita Mikhailova, The Institute of toxicology; Aleksandra Melekhova, The Institute of toxicology)
The using of biological test subjects is necessary for studying safety of chemicals according to OECD methodology. Nowadays GLP principles for in silico studies by means of computer modeling are discussed a lot in Russian Federation and Eurasian Economic Community countries. To use computer methodology test facilities equipment, in particular computer-controlled system, should comply with additional requirements. The using of computer modeling for case study simulations is a part of modern strategy of chemical compound safety development. Representatives of test facilities, regulatory authorities and manufacturers have different points of view on in silico studies results acceptability and recognition. The question of possibility to use open computer platforms for in silico studies would be discussed through the example of QSAR Toolbox project. The question of possibility to join IATA and AOP methodologies followed by risk evaluation to validation with the in vivo and in vitro studies results received by the use of biological test subjects was triggered. Representatives of Russian Federation and Eurasian Economic Community countries suggested the variety of alternative methods that may be used for additional studies to register chemicals by regulatory authorities.
PS-27: Managing Data Review for Long-Term Studies: Critical Points for Data Review – An Introduction to Audit Planning (J Heléne Andersson, Toxikon)
Long-term studies can be challenging due to the volume of data to be reviewed. A good audit plan will help tame the challenge by portioning the data into manageable parts. When data are made available by the Study Director for QA review throughout the conduct of study, keeping track of what has been reviewed minimizes duplication of effort and helps the Study Director address any compliance concerns timely. Having data available for review during the conduct is also less intimidating and more efficient than receiving all the data upon technical completion.
PS-28: Responding to QAU Inspection Findings: A Study Director’s Perspective (Felice Randi LaMadeleine, Toxikon Corporation)
The roles of Study Director and Quality Assurance for the conduct of a nonclinical (GLP) study are integral. It is the Study Director’s responsibility to manage and implement the GLP regulations, and ensure the study both from the scientific perspective and the GLP/regulatory compliance of the study. The Quality Assurance Unit (QAU) assures compliance by inspecting the conduct of the study, and reviewing the data and report generated. The purpose of the QAU inspection is to inform the Study Director and Test Facility Management of any departures from the protocol, SOPs, and GLP regulations. How and when the Study Director responds to these inspectional reports are key to a successful and compliant GLP testing program.
PS-29: Finalizing a Multi-Site GLP Study - Considerations from QAU, Study Director, and Principal Investigator (Megan Lawhead, Charles River Laboratories)
How does a Testing Facility take a multi-site study, wrap it up and put a bow on it for finalization? Quality Assurance, the Study Director, and Principal Investigator must work together to ensure all phases of the study are closed out (audits cleared, study data/materials archived and contributing reports signed off) and available for the finalization and archival of the overall study report. Ensuring compliance with regulations while finalizing a study in an efficient manner requires coordination of key personnel. This presentation will discuss the finalization process from the perspectives of Study Director, Principal Investigator and Quality Assurance.
PS-30: What are the Risks to using a Vendor that is not GLP Compliant? (Aubrey Shelton, Cook Research Incorporated)
This poster will offer guidance on assuring study and data integrity when using vendors that are not GLP (21CFR58) compliant.
Conducting studies following 21CFR58 require test facility management (TFM) to assure adequate resources, facilities, equipment, materials, etc are available. However, TFM may need to seek services outside of the organization to fulfill GLP requirements such as animal care facilities, test article characterization, or laboratory testing.
These services may be provided by vendors that are not compliant to GLP, which could deter TFM from using the vendor. Services provided may be novel or necessary and will add to the success of the project. In these cases, TFM should be aware of the risks to the project and determine how to mitigate (e.g. robust vendor management, QAU oversight) those risks to use the vendor. This poster will discuss identifying, mitigating, controlling, and monitoring risks that may occur when working with a vendor that is not compliant to GLP regulations.
This poster will also provide an example of working with a university animal facility that does not claim GLP compliance. There will be practical examples of identified risks and potential controls. In summary, there are risks to using a vendor that is not compliant to GLP, but risk identification and mitigation strategies will assure the services provided will successfully support GLP compliant studies.
PS-31: Characterization of Emerging Test Articles (Timothy Valley, Covance)
A primary component of the GLP regulations is the characterization of the test article. Typically this involves the assessment of identity, strength; and purity along with stability. Historically these characteristics provided sufficient information for the Study Director to adequately assess the safety of the test article. However new and innovative test articles have emerged and these historical characteristics may not adequately address characterization. In this poster we will explore the information needed to characterize these emerging categories of test articles and how to assess the adequacy of that information.
PS-33: Turning the Internet of Things into Smart Labs (Alice Guimarães, Oswaldo Cruz Foundation)
Continuously improve quality management is to apply Kaizen - continuous improvement - in the workplace. Combined with the evolution of technology, Fiocruz Rondônia has linked to information technology (IT) tools, using Internet of Things (IoT). IoT applications for technological solutions in the daily life of science are absolutely possible and reinforce the importance of expanding the use of this connectivity in favor of research development and quality improvement. We have developed an intelligent monitoring system with an innovative proposal that is an online platform that transforms the way we interact with the laboratory, since, besides just controlling, it adds intelligence and autonomy to the environment, automating and giving security to the quality requirements which require continuous monitoring and adjustment. The laboratory automation project, or monitoring system, is the tool capable of monitoring, storing, managing and controlling parameters in laboratories such as pressure, temperature, humidity, access. The system consists of an open, online platform with free hardware, microcontrollers and sensors. These sensors send data to the platform and this data is stored, converted into information in real time. This information encourages decisions for the user or the system itself to take. All this within a low cost structure provided by the pilot applied in Fiocruz Rondônia. Turning scientific research laboratories into smart laboratories is a wonderful way back, with the key benefits of security, self-sufficiency, and decision-making support.
PS-34: Challenges in Auditing GLP Surgical Studies (J Heléne Andersson, Toxikon)
Non-clinical surgical studies present a challenge for a QAU reviewer accustomed to drug toxicity studies or routine biocompatibility studies as components of both types of studies are being assessed. Often complex medical devices include multiple components, software, or both, and an understanding of how to appropriately apply the regulations can be challenging. Surgical studies are also often more susceptible to unforeseen circumstances and deviations, and in-life inspections often include pre-operative activities, surgical dose administration, and post-surgery monitoring that are outside the routine.
PS-35: Review of ISO 10993-1:2018 (Felice Randi LaMadeleine, Toxikon Corporation)
ISO 10993-1 is the overarching technical reference for the biological evaluation of medical devices within a risk management process. This reference is significant for to the assessment of the biological safety data, generated from biocompatibility testing, for the medical device. The 2018 updates includes risk analysis for the identification of gaps in data available and the identification of additional data necessary in order to determine or analyze the biological safety of the medical devices. ISO 10993-1 is an important standard and the US FDA’s Center for Devices and Radiological Health (CDRH) has issued a guidance document regarding its use.
PS-36: QMS Stats at a Glance... for Medical Device Professionals in a Hurry (Gretchen Upton, FDAQRC)
As a medical device manufacturer, one of the vaguer parts of FDA Part 820, Quality System Regulations is the requirement to make decisions based on statistical techniques. Additionally, ISO 13485:2016 anchors the entire QMS upon an over-riding Quality Policy anchored by measurable Quality Objectives to be reviewed by Top Management at least once per year, or more depending upon trend analyses and signals.
This can be an especially daunting task for small startups as well as established manufacturers. Where to begin? What methods are best? How often should the metrics be reviewed? Within this poster, I will outline the Top 10 QMS systems anchored by statistical techniques, tips and/or methodologies to support the overall analysis of the Quality System.
PS-37: Creating an effective process map of computer systems (Marc Altres, Charles River)
Mapping out a computer system’s data life cycle is an important step in identifying key regulatory risk factors, applying effective mitigation strategies and developing a solid auditing program.
Since 2015, there has been a spike in data integrity related warning letters with respect to computer systems. In Charles River, it was found that a process map can be a vital tool for operations, quality assurance and management for improving communication amongst all the stakeholders and achieving high quality data. Although not required by the regulations, it has been cited by the US Food and Drug Administration (FDA) as a necessary plan for an enterprise. A flow chart of the data life cycle of a computer systems can be a starting point in determining potential data integrity issues as well as help save time and money by recognizing inefficiencies in the process.
The presentation will walk through an example of a computer system process map, assess the risk factors and mitigation strategies of that system and propose an adapted audit plan.
PS-38: The ‘Q’ Factor: How Connected Quality Improves Performance (Robyn Barnes, MasterControl)
As life sciences organizations tackle today’s most difficult health care challenges, they are increasingly obligated to open their doors to auditors, whether for investment capital assessments, regulatory evaluations, or merger and acquisition (M&A) inspections. In the case of the latter, a strong due diligence process is critical to ensuring the acquirer is fully aware of all quality and compliance aspects of the deal. It also provides access to vital intelligence that is used to negotiate the final acquisition and integrate the new site or subsidiary more effectively.
However, making the case for auditing a due diligence process can be awkward if the internal audit function has been unable to systematically generate improvement opportunities. Building strong relationships with the audit committee and management is a key factor, as is the reputation of the internal audit department itself. If either are lacking, it can be difficult to obtain buy-in for auditing the due diligence process, or access to operations for that matter.
A third-party approach may be imperative to effectively draw out the “skeletons in the closet” and get a true sense of the systematic effectiveness and efficiency in organizational improvement. Qualified external auditors can assist a company with ensuring a strong due diligence process is maintained during both pre- and post-acquisition.
This poster will present a framework for quality auditing of an M&A pre-acquisition due diligence investigation process. A case study will be referenced during the presentation to highlight key points of the process.
PS-39: Quality, Biosafety and Environment: tripod of the integrated approach (Saada Fernandez, Oswaldo Cruz Institute-FIOCRUZ; Harrison Gomes, Oswaldo Cruz Institute/ FIOCRUZ; Ricardo Machado, Oswaldo Cruz Institute/ FIOCRUZ; Thiago Trindade, Oswaldo Cruz Institute/ FIOCRUZ; Renata Lapa, Oswaldo Cruz Institute/ FIOCRUZ; Jorge Tardan, Oswaldo Cruz Institute/ FIOCRUZ; Wania Santiago, Oswaldo Cruz Institute/ FIOCRUZ)
In constant search of excellence in the production of science, the Oswaldo Cruz Institute selects as a basis for monitoring processes and services, the QBE tripod, Quality, Biosafety and Environment, joint and multidisciplinary actions that pursue the Compliance requirements. Quality Management has as principle the organization, using tools and practices that make it possible to trace the traceability, veracity and reliability of the information and processes contemplated by the system. In the same way, Biosafety is a set of actions that aims to prevent, reduce or eliminate the risks to workers health and to protect the environment through programs of quality assurance, accident prevention, individual and collective training. Also added, the Environmental Management that addresses the principles of sustainability incorporating actions that lead to the improvement of the environmental performance and impressing responsibilities with the environmental conservation resources and spaces, contributing to the of the supply of present and future human needs. Actions have been practiced, leading to a synergy of these areas, in the search for instruments or standards for the dissemination of an integrative politic that aggregates basal criticism to achieve the institutional objectives and goals.
This proposal: Standardize good practices in the areas of Quality, Biosafety and Environmental Management. Facilitate dissemination of institutional Politics and Support Laboratories in Meeting the Legal Requirements established by the Control, Regulation and Governmental Organs.
Action plan´s action was set out specifying critical requirements for the implementation of a quality system in a unit producing knowledge, products and services in the biomedical area.
PS-40: Roles of GLP QA vs. GMP QA – The Similarities and Differences (Joshua Hittle, Charles River Laboratories, Inc.; Deanna Talerico, Charles River Laboratories, Inc., Ohio; Megan Callan, Charles River Laboratories; Christine Garvey, Charles River Laboratories, Inc.)
The GLP (21 CFR Part 58 and 40 CFR Parts 160 and 792) and GMP (21 CFR Parts 210, 211, and ICH Q10) regulations specify that a Quality Assurance Unit/Quality Control Unit, respectively, will be established to monitor and oversee the work performed per applicable regulations. While there are similarities in the roles and responsibilities, there are also stark differences between QAs role and responsibilities within the regulations. Understanding the similarities and differences and the reasoning are important for Quality Assurance auditors working at a site that supports GLP and/or GMP. In addition, the full understanding of both regulatory requirements allow for more effective and efficient methodology for anyone auditing facilities claiming compliance to either regulation. This poster will highlight the similarities and differences between the regulations, providing a clear understanding of the roles and responsibilities of GLP QA and GMP QA.
PS-41: The Hospital Accreditation process and the improvement on the provision of quality of the assistance services on the Oswaldo Cruz Foundation, Brazil (Renata Souza, Oswaldo Cruz Foundation; Saada Fernandez, Oswaldo Cruz Institute-FIOCRUZ; Patricia Ribeiro, Oswaldo Cruz Foundation)
Accreditation is defined as an educational and voluntary process of assessing the quality certification of health services. The Oswaldo Cruz Foundation is a federal institution linked to the Brazilian Ministry of Health. Created in 1900, Fiocruz seeks to interconnect the areas of science, technology and health, and carries out activities ranging from outpatient consultations to the manufacture of vaccines and medicines. Currently, there are more than 80 thousand outpatient visits and almost 130 thousand procedures, in addition to thousands of hospitalizations. Thus, Fiocruz chose to conform to international quality standards through the formal recognition granted by the Hospital Accreditation tool. Initially five Fiocruz Assistance Units participated in the process. The model chosen was Joint Commission International, an American accrediting institution and recognized by The International Society for Quality in Health Care (ISQua). Stages such as: definition of standards, construction of documents, creation of indicators, personel training, among others were part of the scope of activities to be fulfilled to implant the chosen model. The implementation of the JCI standards with the consequent accreditation, provided numerous improvements in the assistance services offered by Fiocruz, such as: participative planning, improvement in clinical-administrative indicators, focus on patient safety, among others. Currently, the institution continues to implement the accreditation model, but is in the process of moving to a national institution, the National Accreditation Organization (ONA), and intends to recertify its main outpatient clinics in this process, which only brought benefits to the institution's healthcare area.
PS-43: Quality control of the preclinical archive transfer (Maria Zaytseva, The institute of toxicology; Lidia Lyanginen, The Institute of toxicology; Yuriy Vikharev, FSSI The Institute of Toxicology FMBA RF)
The archiving of data generated during the course of a non-clinical research is one of the key aspects of quality assurance system. Within this context administration of test facilities should ensure appropriate maintenance of preclinical research records and materials as well as other documentation needed to be verified by monitoring authority to confirm the compliance with GLP principles. On occasion (overloading of the archive facilities, moving of test facilities etc.) it may be necessary to transfer archive to another room or building at a different physical location. Transferring of archive is a high-priority task for administration of test facilities and archivist. Transferring of archive can be undertaken by test facility itself as well as by process-specialized outside agency. Major issues to be settled in the process of archive transferring: 1. Drawing up inventory of records and materials. Inventory should contain all records and materials including histological samples and test subjects. As it may be necessary to do paper and electronic copies of the most valuable documents. 2. Packing of records and materials. Records and materials should be packed in a way to ensure their safety and protection from environmental hazards influence by means of special labeled packing for rainfall, light and mechanic damages protection. 3. Load handling. To transfer archive within one building moving carriers and other transportation facilities are used. 4. Arrangement of records and materials and reviewing against the inventory. Hard-copy record with data about transfer date and original location should be placed into each folder. Transferring of [cut off on submission]