CASE STUDY: QUALITY TOLERANCE LIMITS Exploring the Path From Definition to Implementation of Quality Tolerance Limits at Pfizer

Transcription

1 October 10-12, 2018 Sonesta Hotel Philadelphia Philadelphia, PA 9th Annual Clinical Quality Oversight Forum Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and S ites FEATURED SESSIONS INDUSTRY SURVEY RESULTS: CRO OVERSIGHT EFFECTIVENESS AND IMPACT Benchmarking and Understanding the Industry s CRO Oversight Practices, Their Impact and Effectiveness With New Industry Research Results Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC. CASE STUDY: INTERNAL COMMUNICATION OPTIMIZATION Optimizing Oversight Through Effective Communication Between Clinical Quality and Clinical Operations Karine Julien, Executive Director, Therapeutic Area Head, Primary Care, and Interim Pharmacovigilance Head, MRL Quality Assurance, MERCK Christina Salerno, Executive Director, Head, Clinical Sciences and Study Management, Primary Care, Interim Head, HQ Clinical Quality Management, MERCK CRITICAL PROCESSES AND DATA IDENTIFICATION Examining the Protocol to Identify Those Processes and Data That Are Critical and Impact the Oversight Approach Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC CASE STUDY: QUALITY TOLERANCE LIMITS Exploring the Path From Definition to Implementation of Quality Tolerance Limits at Pfizer Melissa Suprin, Head, Clinical Quality Risk Management, PFIZER Michael Wilkinson, Senior Research Analyst, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT REAL CASE STUDIES OF AVOIDABLE FAILURES Examining Fundamental Failures by Top CROs Identified Through Audits and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK CASE STUDY: QUALITY AGREEMENTS Understanding the Purpose and Value of Quality Agreements and Outlining the Essential Elements JoAnna Brodie, Director, Clinical Quality Assurance Third-Party Resourcing, GLAXOSMITHKLINE CONFERENCE CHAIR Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC. THREE INTERACTIVE WORKSHOPS ON OCTOBER 10 BREAKFAST WORKSHOP CRO Oversight Post ICH E6 R2 LUNCH WORKSHOP Mitigating Risk at the Site Level DINNER WORKSHOP Quality Tolerance Limits Stay Connected #CQOF Sponsors and Exhibitors Proactive GCP Compliance Consortium Partner Supporting Partner

2 2017 Audience Profile Company Size of Trial Sponsors 9th Annual Clinical Quality Oversight Forum 15% Non-CRO Clinical Service Providers Company Type Venue 10% CROs 5% Other 70% Pharma, Biotech and Device Companies Sonesta Hotel Philadelphia 1800 Market St. / Philadelphia, PA % Small Pharma, Biotech or Device Companies To make reservations, guests can call SONESTA and request the group rate for ExL s October Meetings or visit 28% Large Pharma, Biotech or Device Companies 34% Mid-Sized Pharma, Biotech or Device Companies The group rate is available until September 18, Please book your room early, as rooms available at this rate are limited. *ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided. Sponsorship and Exhibition Opportunities Do you want to spread the word about your organization s solutions to potential clients and prospects in attendance? Take advantage of the opportunity to exhibit, present an educational session, share your expertise on a panel discussion, moderate a roundtable, host a networking event and/or distribute promotional materials at this conference. ExL works closely with our sponsors to create customized opportunities to fulfill your conference objectives. Questions? Comments? Do you have questions or comments on the agenda? Is there a specific topic missing that you would like to see addressed? Would you like to get involved as a speaker, panelist or roundtable moderator? Dear Colleague The CQOF has become THE annual event for clinical quality professionals to network with, learn from and benchmark against their peers. The CQOF provides an interactive forum for senior-level clinical quality and operations professionals to engage, discuss and share their challenges, best practices and experiences in developing effective clinical quality oversight strategies that incorporate risk-based approaches to ensure their vendors and sites are compliant and inspection ready. Participants leave with practical tools and knowledge to optimize their oversight efforts and mitigate risks in their clinical trials. I look forward to seeing you in October. Please don t hesitate to reach out with any questions. Sincerely, Kristen Hunter Kristen Hunter Event Director khunter@exlevents.com Who Should Attend? The event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas: Quality Management/Clinical Quality Management Clinical Quality Assurance/QA/CQA Clinical Quality Control/QC/CQC Clinical Operations/Management/Research/ Development Compliance/Clinical Compliance/Regulatory Compliance Monitoring/Site Management/Study Management Clinical Outsourcing/Vendor Management/Third- Party Management Good Clinical Practice/GCP Auditing/Auditor Clinical Risk/Risk Assessment Regulatory Affairs Medical Affairs The event is also of interest to: Investigative Sites Academic Research Organizations Central, Imaging and ECG Labs IVRS Companies EDC Companies Other Clinical Service Providers

3 Wednesday, October 10, 2018 Workshop Day 7:30 Registration and Continental Breakfast 8:15 BREAKFAST WORKSHOP: CRO OVERSIGHT POST ICH E6 R2 Examining the Impact of ICH E6 R2 on CRO Oversight and Ensuring Compliance Liz Wool, President, WOOL CONSULTING GROUP, INC. Evaluating ICH E6 R2 and identifying the requirements for sponsors and CROs related to the oversight of outsourced clinical trial activities, tasks, etc. Understanding what specific elements of R2 impact oversight Interpreting the oversight expectations and comparing them to select regulatory authorities Discussing responsibilities for the oversight of subcontractors Assessing adherence to ICH E6 R2 requirements and identifying any gaps Appraising your current CRO-Vendor oversight practices Conducting a gap analysis to identify areas of noncompliance Discussing methodologies for R2 adherence Designing/Redesigning your oversight program or compliance Walking through the critical elements of an ICH E6 R2 compliant oversight program Translating results from the gap analysis into actions Examining strategies for maintaining an effective and compliant oversight program 9:45 15-Minute Break 10:00 Breakfast Workshop Continues 11:30 Breakfast Workshop Concludes/Registration for Lunch Workshop 12:00 LUNCH WORKSHOP: MITIGATING RISK AT THE SITE LEVEL Examining Common Challenges and Obstacles From the Site s Perspective and Proactive Approaches the Trial Sponsor/CRO Can Take to Avoid Them Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC. Assessing the protocol Understanding common risk areas for sites from the protocol Conducting protocol feasibility and optimization assessments Evaluating varying protocol optimization strategies and tools Helping sites translate the protocol into practice through effective study implementation strategies Training optimization Discussing where most sites lack training and the issues that result Evaluating different approaches to training and understanding what works and what doesn t from the site s perspective Customizing training programs for maximum impact Proactive approaches Identifying simple things sponsors/cros can do to optimize site performance and mitigate risk 12:45 45-Minute Break for Lunch 1:30 Lunch Workshop Continues 3:45 Lunch Workshop Concludes/Registration for Dinner Workshop 4:30 DINNER WORKSHOP: QUALITY TOLERANCE LIMITS Understanding the Methodology for Establishing and Maintaining Appropriate Quality Tolerance Limits (QTLs) Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Develop Defining QTLs and understanding their purpose Evaluating the requirements driving the development of QTLs Examining the protocol to identify the critical processes and at what stages human subject protection and/or data integrity could be impacted Examining proposed study sites to identify processes and patient flow and at what points protocol implementation could be impacted Documenting the development process Apply Implementing the established QTLs Tracking and assessing the data to establish whether they are within the tolerance limits Responding when things move beyond the established thresholds Adjust Recognizing that QTLs evolve over time and can be ramped up or ramped down depending on the circumstances Evaluating the situation to determine if the QTLs need to be adjusted Documenting to justify any changes in the QTLs 6:00 60-Minute Break for Dinner 7:00 Dinner Workshop Continues 8:30 Dinner Workshop Concludes

4 Thursday, October 11, 2018 Main Conference 7:45 Registration and Continental Breakfast 8:30 CHAIRPERSON S WELCOME AND INDUSTRY UPDATE Angela Berns, Director and Head of Vendor Management, Clinical Quality Assurance, UCB BIOSCIENCES INC. 9:00 INDUSTRY SURVEY RESULTS: CRO OVERSIGHT EFFECTIVENESS AND IMPACT Benchmarking and Understanding the Industry s CRO Oversight Practices, Their Impact and Effectiveness With New Industry Research Results Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC. Michael Wilkinson, Senior Research Analyst, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT Analyzing the types of CRO oversight models used for a variety of outsourcing approaches Identifying common oversight challenges and areas for improvement Determining the effectiveness of various oversight processes, including management structures, performance metrics monitoring and more INDUSTRY SURVEY "The Clinical Quality Oversight Forum in October was EXCELLENT! This was my first time attending an ExL event and I was very happy with my experience. The content was well presented, the presenters were engaging and everything was just so organized and well done. What I liked most was that the level of the content was meant for moderate to highly experienced individuals in QA it's often hard to find something that isn't just an 'intro to QA.'. I am looking forward to attending more ExL events in the future. Senior Associate, Clinical Quality Assurance, EISAI INC. 10:00 Networking and Refreshment Break 10:30 SENIOR LEADERS PANEL: PRIORITIZING QUALITY Driving Quality From the Top Down to Build a Successful Quality Culture Moderator Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP Panelists Kira Drummond, Head, R&D Quality and Compliance, ALEXION PHARMACEUTICALS, INC. Federico A. Feldstein, JD, Vice President, Head of R&D Quality and Compliance, JOHNSON & JOHNSON Additional Panelists TBD Defining the purpose and goal of a quality culture Identifying the critical success factors Examining best practices for initiating the shift from a reactive issue-based focus to a proactive risk-based focus Determining the organization s risk tolerance level Driving quality as a priority among all stakeholders CASE STUDIES PANEL DISCUSSION 11:30 REAL CASE STUDIES OF AVOIDABLE FAILURES Examining Fundamental Failures by Top CROs Identified Through Audits and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK Examining detailed accounts of failures in quality standards in areas of critical impact Asking the right questions to uncover execution errors in real time Discussing how these issues could have been avoided with effective oversight and performance metrics Outlining proactive measures to perform in real-time to avoid retrospective reactions following audits 12:30 Lunch TRACK A 1:30 CRITICAL PROCESSES AND DATA IDENTIFICATION Examining the Protocol to Identify Those Processes and Data That Are Critical and Impact the Oversight Approach Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Understanding the elements of the protocol that are critical and impact subject safety and/or data integrity --Breaking down a mock protocol into the critical elements Evaluating the risks related to those identified critical processes and data --Identifying risks on both the system and trial levels Assessing how these high-risk areas should impact your oversight approach Describing how to effectively document this identification process TRACK B QUALITY CULTURE IMPLEMENTATION Executing and Effective Change Management Approach to Build and Sustain a Quality Culture Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Director, Quality Assurance, INSEPTION GROUP Karen Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP Understanding the importance of change management when it comes to initiating and sustaining a cultural shift Examining both the process and human sides of change and how they should be addressed Preparing for change by defining a clear outcome, conducting assessments to determine the degree of change needed, and identifying change leaders Developing a transitional plan to communicate, implement and train Evaluating the result, addressing gaps and determining next steps for sustainability

5 Thursday, October 11, 2018 Main Conference 2:15 CASE STUDY: QUALITY TOLERANCE LIMITS Exploring the Path From Definition to Implementation of Quality Tolerance Limits at Pfizer Melissa Suprin, Head, Clinical Quality Risk Management, PFIZER Defining quality and risk in the quality management system Establishing risk management fundamentals by identifying, evaluating and controlling risks the identified risks and the design of the trial to determine quality tolerance limits Meeting ICH E6 R2 requirements by measuring performance, implementing remediations and including in the CSR Overseeing and monitoring the performance of QTLs across the trial portfolio 3:00 Networking and Refreshment Break 3:30 MONITORING POST-R2 Evaluating Systemic Changes to Monitoring That Must Occur As a Result of ICH E6 R2 Steve Young, Chief Operations Officer, CLUEPOINTS Identifying the elements of ICH E6 R2 that relate to monitoring Evaluating those elements and their impact on monitoring including on-site, remote and centralized Translating those elements into a risk-based methodology for monitoring Understanding and addressing the perspective of sites with respect to risk-based monitoring Assessing the impact of risk-based monitoring on the relationship between sponsor and CRO 4:15 ROUNDTABLE DISCUSSIONS CASE STUDY: VENDOR AND SITE SELECTION Identifying a Complementary Quality Culture Among Vendors and Sites to Mitigate Risk Sarah Jane Constantine, Director of Clinical Operations, IMMUNOGEN, INC. Donna-Lee Destouche, M.Sc., CCRP, Senior Clinical Trial Manager, Clinical Development, IMMUNOGEN, INC. Conceptualizing what you are looking for in a partner and prioritizing attributes Evaluating their quality culture to determine if it s in line with your own Determining which predictive metrics matter the most for identifying potential risk areas Conducting audits to ensure their quality standards and culture are in line with your expectations CASE STUDY: QUALITY AGREEMENTS Understanding the Purpose and Value of Quality Agreements and Outlining the Essential Elements JoAnna Brodie, Director, Clinical Quality Assurance Third-Party Resourcing, GLAXOSMITHKLINE Defining the purpose of quality agreements and recognizing the need Understanding the differences between the quality agreement, the contract and other documents and how they should relate Evaluating who should develop and enforce the quality agreement Outlining how the quality agreement should be structured and the essential elements Each conference participant selects one topic from the following list to discuss in an intimate setting. You ll be asked for your topic selections via a few weeks out from the conference and will also have the opportunity to sign up on site. CASE STUDY 1. CLINICAL STUDY REPORTS (CSRs): Understanding What Should and Should Not Be Included in the CSRs 2. CLINICAL CAPAs: Sharing Best Practices for Defining, Communicating, Tracking and Managing CAPAs 3. WEARABLE DEVICES IN TRIALS: Discussing the Use of Wearables (e.g., Fitbits) to Collect Trial Data and How That Data Is Validated and Handled During Inspections 4. OVERSIGHT OF THIRD-PARTY CONTRACTORS: Evaluating Regulations and Best Practices for Oversight of Third-Party Contractors/Vendors Hired by the CRO 5. VIRTUAL TRIALS: Discussing the Quality Issues Related to Virtual Clinical Trials 6. CHINA INSPECTIONS: Sharing Experiences With Inspections in China and How to Prepare 7. TRAINING OPTIMIZATION: Examining Different Training Methodologies and Discussing Their Effectiveness 8. VENDOR AND SITE SELECTION: Identifying a Complementary Quality Culture Among Vendors and Sites to Mitigate Risk 9. KNOWLEDGE MANAGEMENT: Discussing Knowledge Management As a Critical Success Factor for Effective Oversight 10. QUALITY BY DESIGN: Building Quality Into Trial Operations at the Onset to Ensure Quality Is the Priority and Streamline Oversight 11. TRIAL MASTER FILE (TMF): Leveraging the TMF As an Oversight Tool to Ensure Data Integrity and Maintain an Inspection-Ready State 12: DOCUMENTING VENDOR OVERSIGHT: Achieving Compliant Documentation of Proper Ongoing Engagement and Evaluation of Clinical Vendors 5:00 Day Concludes CASE STUDY CASE STUDY Media Partners TM PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT

6 Friday, October 12, 2018 Main Conference 8:00 Registration and Continental Breakfast 8:30 CHAIRPERSON S WELCOME AND KEY LEARNING POINTS FROM PREVIOUS DAY Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC. 8:45 REGULATORY UPDATE: FDA INSPECTIONS Identifying Recent Site Inspection Trends and Strategies for Building Quality Into Clinical Research to Prevent Critical Compliance Issues FDA (invited) Sharing and interpreting recent site inspection trends Understanding what to expect during an inspection and how to best work with the FDA during an inspection Examining how site inspections are evolving as the industry moves towards risk-based approaches Responding to 483s after an inspection and subsequent regulatory correspondence 10:45 Networking and Refreshment Break TRACK A 11:15 THE IMPACT OF R2 ON SITES Evaluating the Impact of ICH E6 R2 on Sites and How Sponsors Can Proactively Manage This Change to Optimize Quality Steve Whittaker, Senior Consultant, THE AVOCA GROUP Examining the elements of ICH E6 R2 that directly impact sites Recognizing that risk-based monitoring shifts QC from the responsibility of the Sponsor/CRO to that of the site --Exploring the impact of this shift and how to ensure sites understand their changing role Ensuring data quality and integrity at the site level 12:00 QUALITY OPTIMIZATION AT THE SITE LEVEL Comparing the Wants and Needs of the Sponsor/CRO With Those of the Sites to Ensure Quality Is the Priority Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC SITE REPRESENTATIVE TBD Examining the protocol and ensuring comprehension by sponsor, CRO and site through effective training Identifying the challenges and complexities of the study and modifying oversight accordingly Ensuring the CRO and site are equipped to handle the challenges of the study Building frequent oversight checks into operations to ensure quality and compliance 9:45 PANEL DISCUSSION: VENDOR AND SITE OVERSIGHT CHANGES AS A RESULT OF ICH E6 R2 Sharing Real-World Case Studies Showing the Actions and Process Adjustments That Resulted From ICH E6 R2 Panelists Sheri Kuss, Director, Clinical Quality Lead, PFIZER Cheri Wilczek, President, CLINAUDITS, LLC Additional Panelists TBD Examining how oversight operations were assessed to determine where adjustments needed to be made to ensure compliance Conceptualizing action plans and aligning responsibilities Evaluating the challenges and obstacles and how they were overcome Discussing lessons learned and what could have been done better PANEL DISCUSSION 12:45 Lunch TRACK B SITE ACCREDITATION AND STANDARDS INITIATIVE (SASI) Ensuring Site Quality With the Adoption of a Global Standard and Independent Accreditation Larry Kennedy, Ph.D., Vice President, Quality Management Systems, Chief Quality Officer, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES); CEO, QUALITY MANAGEMENT INSTITUTE Understanding the drive to develop this accreditation program Discussing the purpose of SASI and how it works --Setting reasonable standards that are above minimal requirements to build an industrywide foundation for quality at the site level --Developing the process for dynamic accreditation --Recognizing and rewarding excellence Outlining the specifics of the standards that must be achieved to be accredited Evaluating the timeline for piloting and availability CASE STUDY: INTERNAL COMMUNICATION OPTIMIZATION Optimizing Oversight Through Effective Communication Between Clinical Quality and Clinical Operations Karine Julien, Executive Director, Therapeutic Area Head, Primary Care, and Interim Pharmacovigilance Head, MRL Quality Assurance, MERCK Christina Salerno, Executive Director, Head, Clinical Sciences and Study Management, Primary Care, Interim Head, HQ Clinical Quality Management, MERCK Outlining clinical and quality responsibilities Understanding the importance of having an established communication plan Defining a collaborative process to assign accountability and ensure effective oversight occurs Evaluating when the two groups should work together and when independence must be maintained Detailing realized benefits to oversight through improved internal collaboration CASE STUDY

7 Friday, October 12, 2018 Main Conference 1:45 PANEL DISCUSSION: INSPECTION OF OVERSIGHT ACTIVITIES PANEL Discussing How Oversight Activities and Processes Were Evaluated During Inspections Panelists Steve Whittaker, Senior Consultant, THE AVOCA GROUP Additional Panelists TBD Sharing panelists experiences with inspections related to oversight activities Understanding what kind of documentation was used to show oversight and how it was received Discussing expectations related to escalation plans and CAPAs Resulting procedural changes to oversight as a result of an inspection Recommendations for being inspection-ready when it comes to demonstrating effective oversight 2:45 CHAIRPERSON S CONCLUDING REMARKS Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC. 3:00 Close of Conference "The conference and speakers were all excellent. This was a very valuable conference and input from the participants will improve our quality oversight of vendors." Auditor, Quality Assurance, INFINITY PHARMACEUTICALS "The conference was a positive open forum that provided an opportunity for sponsors and vendors to come together and share experiences, lessons learned, and identify a path to improve sponsor oversight through better channels of communication." Associate Director, Global R&D Quality Assurance, SHIRE PHARMACEUTICALS "What a great conference (as usual!). The speakers are always top notch and the topics are always the ones that are most pressing for us to address as an industry... not to mention the flawless execution of all the moving parts that EXL manages! Nice job as always!" Senior Consultant, THE AVOCA GROUP "My compliments to the entire ExL Pharma Team for how you operate. You have a well-oiled operation. Everyone has a positive 'can do' attitude. The entire experience was extremely positive and I can t thank you enough!" 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8 Five Ways to Register: Method of Payment: q Check q Credit Card Mail: PMA Conference Management, POB 2303 Falls Church VA Make checks payable to: ExL Events, Inc. Card Type: q MasterCard q Visa q Discover q AMEX Online: CLICK HERE Card Number: Exp. Date: CVV: register@pmaconference.com Name on Card: Phone: Signature: Please contact me: Fax: q I m interested in marketing opportunities at this event. q I wish to receive updates on ExL Pharma s upcoming events. q Register me for an All-Access Pass (Includes all sessions, all three days). CONFERENCE CODE: q Register me for the Main Conference Only (Includes all sessions on Oct 11-12). q Add on Oct 10 Breakfast Workshop on CRO Oversight Post ICH E6 R2 q Add on Oct 10 Lunch Workshop on Mitigating Risk at the Site Level q Add on Oct 10 Dinner Workshop on Quality Tolerance Limits Name: Title: Company: Dept.: Address: City: State: Zip: Phone: Fax: 9th Annual October 10-12, 2018 Sonesta Hotel Philadelphia Philadelphia, PA Clinical Quality Oversight Forum Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites FEATURED SESSIONS REAL CASE STUDIES OF AVOIDABLE FAILURES Examining Fundamental Failures by Top CROs Identified Through Audits, and How Effective Oversight Would Have Prevented Them Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK CONFERENCE CHAIR Angela Berns, Director and Head of Vendor Management, UCB BIOSCIENCES INC. THREE INTERACTIVE WORKSHOPS ON OCTOBER 10 BREAKFAST WORKSHOP CRO Oversight Post ICH E6 R2 LUNCH WORKSHOP Mitigating Risk at the Site Level DINNER WORKSHOP Quality Tolerance Limits Sponsors and Exhibitors CRITICAL PROCESSES AND DATA IDENTIFICATION Examining the Protocol to Identify Those Processes and Data That Are Critical and Impact the Oversight Approach Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Stay Connected #CQOF Consortium Partner Proactive GCP Compliance Supporting Partner