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Contact Hours: 1 per session, attended Live.
Presenter(s) - Module 1:
Anthea Dransfield, BSc, MSc, CChem, MRSC, Managing Director, Advarra Consulting Leslie Paul, MS, Director, Advarra Consulting
Presenter - Module 2:
Jan Holladay Pierre, MPH, CMQ/OE, Principal (GCP), IQVIA Quality Compliance Solutions
Presenter - Module 3
Jan Holladay Pierre, MPH, CMQ/OE, Principal (GCP), IQVIA Quality Compliance Solutions
Presenter - Module 4:
Billy Dirkes, VP Quality Assurance, Clinical Research
Presenter - Module 5:
Valaria McGee, Senior Director, PPD
Debby Brown, Senior Director, PPD
Series Sponsored by Advarra
Original Series Dates & Times:
Module 1: Tuesday, August 9, 2022, 12PM ET
Module 2: Tuesday, August 30, 2022, 12PM ET
Module 3: Tuesday, September 6, 2022, 12PM ET
Module 4: Tuesday, September 13, 2022, 12PM ET
Module 5: Thursday, September 22, 2022, 12PM ET
Series Description:
This 5-part webinar series will provide you with the knowledge, tips, tools & case studies that will help prepare your site for an FDA inspection. We will start by addressing the critical question, “Why would the FDA be coming to my site?” Our expert line-up of speakers will not only help to put your site in the right mind-set, but throughout the course and modules they will share key elements of what to expect from an FDA inspection at various stages and phases. Learn how and what to prepare for the visit from the time the Inspector arrives at your door, questions and requests throughout the inspections, possible outcomes, how to implement a corrective action plan, and the long term meanings for your site. We will share how to write the actual response inclusive of who should write it, critical content, as well as specific response examples.
Furthermore, this course will cover the role of risk based monitoring, specifically that all data isn’t inspected equally and what sites should be prepared for. To conclude the module series, we will also provide an overview of how the inspection affects each stakeholder; IRB, Sponsor and site.
Module 1: “Preparing for an Inspection”
Module 2: “Day of Call - In the Door”
Module 3: “Day of Visit - The People”
Module 4: “Responding/Reactions/Corrective Action - Post Visit”
Module 5: “Role of RBM - How the Inspection Affects all of the Stakeholders”
Speaker Bios:
Anthea Dransfield, BSc, MSc, CChem, MRSC, Managing Director, Advarra Consulting - Quality Center of Excellence
With over 25 years of experience within analytical and manufacturing aspects of cGMP, operational leadership of clinical sites, and quality oversight spanning GxP, Anthea brings a practical approach to Quality. She advocates for structured, phase-appropriate procedures that are defendable and enable compliance. She has a drive for process and attention to detail with a focus on using technology to ease the quality burden.
Leslie Paul, MS, Director, Advarra Consulting
Leslie is a Quality Compliance professional with over 30 years of experience in the FDA-regulated industry. Paul is a former US FDA Investigator experienced in Drug, Medical Device, and Bioresearch Monitoring program inspections. Prior industry roles span the full product lifecycle and include Drug Discovery, R&D, Product Development, Clinical Trials, Quality Assurance, and Auditing. Experienced in leading cross-functional & virtual teams to establish and improve Quality Compliance systems and programs, including Quality Governance programs, Internal, Supplier & Clinical QA Audit programs, inspection readiness, regulatory landscape monitoring, and GxP Training.
Jan Holladay Pierre, MPH, CMQ/OE, Principal (GCP), IQVIA Quality Compliance Solutions
Over 25 years in the R&D and healthcare industry with expertise in regulatory compliance (Former FDAer) and quality assurance. SME in GCP, GvP, and GLP/GCLP with experience auditing against FDA requirements and other standards in support of pharmaceutical and medical device clinical trials such as ICH, ISO, HHS/HIPAA, EU/GDPR and CMS/CLIA. Experience in detecting inherent compliance risks with insights and perspectives working in government, sponsor/Pharma, CRO, site, service providers (vendors), specialty labs and hospitals.
Billy Dirkes, VP Quality Assurance, Clinical Research
Billy is an experienced quality assurance professional and has held multiple roles within GCP quality across all phases of human clinical research in both Pharma, PPD, and Accelerated Enrollment Solutions for over 20 years. Billy started his career as a study coordinator and transitioned into Quality Assurance holding multiple auditor positions conducting many audit types in multiple countries. He established a GCP QA function within a new Pharma company and later helped design and lead Quality Management System functionality within PPD in the areas of Global Process Auditing, QA Inspection Management/Consultation/Special Investigations, Global Internal Auditing, and then transitioned into leading the AES QA functions. Billy has direct experience in Global GCP implementation, Good Pharmacovigilance Practices, and Computer System Validation and Compliance principles. In addition, he has held lead roles in inspection management for multiple regulatory authority inspections including FDA, EMA, MHRA, PMDA, and Health Canada. Billy has a B.S. degree in Biomedical Science from Texas A&M University.
Billy believes in a collaborative approach to quality. Quality Assurance is a vital component of any quality management system, but cannot be successful without Operational partners will.
Valaria McGee, Senior Director, PPD
Valarie McGee is a Senior Director and leads the Systems and Innovation group within Project Delivery Process and Systems Optimization (PSO) at PPD, a ThermoFisher company. The Systems and Innovation team focuses on providing the knowledge and expertise to ensure that Project Delivery has industry-leading, operationally effective systems to manage projects efficiently and expertly from start-up to completion. In addition, the Systems and Innovation business segment provides input and influence into future systems and business transformation decisions, in partnership with the other PSO business segments, to streamline and integrate technology into Project Delivery.
Valarie joined PPD in 2002 as a CRA in North America working in therapeutic areas such as infectious disease and gastroenterology. Since that time, she has held the positions of Clinical Team Manager and People Manager of CRAs and People Managers. Valarie moved into the Director level within the Clinical Operations department in 2018 and transitioned to Project Delivery in 2021. Prior to joining PPD, she worked in medical device endocrinology and oncology research and development as a Research Biochemist. During graduate school, Valarie worked in the field of forensic science in crime scene investigation and forensic detection and taught undergraduate organic chemistry.
Valarie holds a master’s degree in Biochemistry from the University of Alabama. She is a member of the Association of Clinical Research Professionals and was a silver medal winner at the Pharmatimes Clinical Researcher of the year team competition in 2015. She has a teenage son, two cats and, in her free time, she enjoys golfing and reading a great mystery. Valarie is an enthusiastic supporter of the arts and is the Vice Chairman of the board for the Chattanooga Boys Choir.
Debby Brown, Senior Director, PPD
Debby Brown has more than 25 years of industry experience including CRO and BioPharma positions. Her current role is Senior Director for PPD with focus on RBQM. In this role, she serves as an internal consultant and provides support to staff around ICHE6R2 adherence. Prior to this, she served in many roles in operations. Debby began as a CRA and has had responsibilities including leading a business unit. She has worked for both Biotech and CRO providers during my career. Debby loves the challenges that come with drug development and loves to see treatments which are possible because research and development is possible.
Society for Clinical Research Sites, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
To obtain your Contact Hours for this webinar:
- The webinar must be watched in its entirety.
- The post webinar survey immediately following this webinar must be completed in its entirety.
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Planners, presenters, faculty, authors, and content reviewers do not have any relevant financial relationships with any commercial interest.
This webinar does not imply any endorsement of products or services by the Society for Clinical Research Sites or ANCC.
The materials and recording of this webinar will be available for one year as an archive, but will not award any contact hours.